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calendar

1,520 catalysts · 4,728 grant · 3,045 8k filing · 2,634 approval · 2,175 device 510k · 1,759 device recall · 1,520 device pma

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2026-08-10: 0 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device pma×from 2025-08-06×clear all
type
  • grant4,728
  • 8k filing3,045
  • approval2,634
  • device 510k2,175
  • device recall1,759
  • device pma1,520
device adverse event
1,000
  • recall593
  • earnings579
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Aug 4, 2025

    30
    ›Aug 6, 2025device pma370d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma370d agoMedtronic, Inc. — Consulta CRT-P (C4TR01); Syncra CRT-P (C2TR01) (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma370d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma370d agoMentor Corp. — Mentor MemoryGel® Breast Implants (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Aug 6, 2025device pma370d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma370d agoMedtronic Neuromodulation — Master Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma370d agoMedtronic Minimed, Inc. — Simplera Sync Sensor, Guardian 4 Sensor (PMA)Medtronic USA Inc

    Product code: SFI. Advisory committee: CH. Decision: APPR

    full page →fda device pma ↗
    ›Aug 6, 2025device pma370d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

    full page →fda device pma ↗
    ›Aug 6, 2025device pma370d agoMedtronic, Inc. — Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01) (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoLife Technologies Corporation — Oncomine™ Dx Express Test (PMA supplement)

    Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoBiomet Manufacturing Corp — Oxford™ Knee System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoTerumo Medical Corporation — Angio-Seal Vascular Closure Device (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoRoche Molecular Systems, Inc. — cobas® HBV (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MKT. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoBiomet Manufacturing Corp — Oxford Partial Knee System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NRA. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoW. L. Gore & Associates, Inc. — EXCLUDER BIFURCATED ENDOPROSTHESIS (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoABBOTT MEDICAL — TactiFlex™ Ablation Catheter, Sensor Enabled™ (PMA supplement)

    Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoBiosense Webster, Inc. — VARIPULSE™ Platform; VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 7, 2025device pma369d agoMedinol, Ltd. — EluNIR-PERL™ Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

    Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoBoston Scientific Corp — Eluvia™ Drug-Eluting Vascular Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: NIU. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoABBOTT MEDICAL — Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (PMA supplement)Postsurgical Therapeutics Inc

    Supplement type: Normal 180 Day Track No User Fee. Product code: NXW. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoAbiomed, Inc. — Impella CP with SmartAssist System (PMA supplement)Abion Inc

    Supplement type: 135 Review Track For 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoNyxoah S.A. — Genio® System 2.1 (PMA)Nyxoah SA

    Product code: MNQ. Advisory committee: AN. Decision: APPR

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoMentor Corp. — MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants (PMA supplement)

    Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoAbbott Molecular, Inc. — Vysis CLL Fish Probe Kit (PMA supplement)

    Supplement type: 30-Day Notice. Product code: PNK. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoMentor Worldwide, LLC — MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (PMA supplement)Revalesio Corp

    Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoLife Technologies Corporation — Oncomine Dx Target Test (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoBoston Scientific Corporation — lnnova™ Vascular Self Expanding Stent (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoMentor Worldwide, LLC — MENTOR™ MemoryShape™ Breast Implants (PMA supplement)

    Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoBoston Scientific Corp — Epic™ Vascular Self-Expanding Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗

    Week of Aug 11, 2025

    20
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma
    ← prev
    page 1 of 31
    next →
    364d ago
    Lenstec, Inc. — Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM (PMA supplement)

    Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (PMA supplement)DFB Soria LLC

    Supplement type: 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Se (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CR T- (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoNovocure, GmbH — Optune Lua (PMA supplement)NovoCure Ltd

    Supplement type: Real-Time Process. Product code: SDA. Advisory committee: AN. Decision: APPR

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoLenstec, Inc. — ClearView 3 Lens (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD, Cobalt XT MRI ICD, Srome MRI ICD (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMentor Worldwide, LLC — MemoryShape™ Silicone Gel-Filled Breast Implants (PMA supplement)

    Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMentor Worldwide, LLC — Saline and SPECTRUM™ Saline-Filled Breast Implants (PMA supplement)Revalesio Corp

    Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMentor Corp. — MemoryGel™ Silicone Gel-Filled Breast Implants (PMA supplement)

    Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $IGC0.2670+0.41%
    $MDT89.41+2.58%
    $NYXH
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $NVCR20.05+28.74%
    $MDT89.41+2.58%
    $MDT89.41+2.58%