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calendar

1,464 catalysts · 4,728 grant · 3,350 8k filing · 2,620 approval · 2,108 device 510k · 1,692 device recall · 1,464 device pma

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type: device pma×from 2025-08-14×clear all
type
  • grant4,728
  • 8k filing3,350
  • approval2,620
  • device 510k2,108
  • device recall1,692
  • device pma1,464
device adverse event
1,000
  • earnings584
  • recall565
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Aug 11, 2025

    26
    ›Aug 14, 2025device pma367d agoBoston Scientific Corp — Blazer™ Open-Irrigated Ablation Catheter (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoMicro Therapeutics, Inc. d/b/a ev3 Neurovascular — Pipeline™ Vantage Embolization Device with Shield Technology™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoAllergan — Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm (hereafter ref (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoBoston Scientific Corp — ROTABLATOR™ Rotational Atherectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoGeneoscopy, Inc. — ColoSense® (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoBoston Scientific — Blazer™ II XP Cardiac Ablation Catheter and Cable (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoAllergan — Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra XC and Ultra Plus XC) (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoSiemens Medical Solutions Diagnostics Limited — IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoSiemens Healthcare Diagnostics, Inc. — IMMULITE 2000 Prostate-Specific Antigen (PSA) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoColoplast Corp. — Titan Inflatable Penile Prosthesis (PMA supplement)

    Supplement type: Real-Time Process. Product code: FHW. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoMedtronic, Inc. — Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoBoston Scientific Corp — Blazer™ II Cardiac Ablation System and Cable (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoBoston Scientific Corporation — POLARx™ Cryoablation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma367d agoIntegrum AB — OPRA™ Implant System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 15, 2025device pma366d agoBiocartis Us, Inc. — Idylla CDx MSI Test (PMA)

    Product code: SFL. Advisory committee: MG. Decision: APPR

    full page →fda device pma ↗
    ›Aug 15, 2025device pma366d agoAgilent Technologies, Inc. — MMR IHC Panel pharmDx (Dako Omnis) (PMA)AGILENT TECHNOLOGIES, INC.

    Product code: QNH. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Aug 15, 2025device pma366d agoNeuspera Medical, Inc. — Neuspera Sacral Neuromodulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 15, 2025device pma366d agoABBOTT MEDICAL — AVEIR™ AR 2 LSP203A Leadless Pacemaker (LP) (atrial) (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 15, 2025device pma366d agoMedtronic, Inc. — Micra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 15, 2025device pma366d agoMedtronic, Inc. — HexaGen™ RF Generator, HexaPulse™ PF Generator, HexaFlow™ Irrigation Pump (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 15, 2025device pma366d agoMedinol, Ltd. — EluNIR™ 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 15, 2025device pma366d agoNevro Corporation — Senza® HFX iQ™ System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Aug 16, 2025device pma365d agoAbbott Vascular — XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra™ Everolimus Eluting Coronary Sten (PMA supplement)Postsurgical Therapeutics Inc

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

    full page →fda device pma ↗

    Week of Aug 18, 2025

    24
    ›Aug 18, 2025device pma363d agoNeuroPace, Inc. — NeuroPace® RNS® System (PMA supplement)NeuroPace Inc

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

    full page →fda device pma ↗
    ›Aug 18, 2025device pma
    ← prev
    page 1 of 30
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    363d ago
    ABBOTT MEDICAL — TriClip Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 18, 2025device pma363d agoZimmer, Inc. — NexGen© LPSFlex/ LPS Mobile Bearing Knee System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 18, 2025device pma363d agoSeikagaku Corp. — SUPARTZ FX (PMA supplement)Seikagaku Corp

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

    full page →fda device pma ↗
    ›Aug 18, 2025device pma363d agoABBOTT MEDICAL — MitraClip Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 19, 2025device pma362d agoBoston Scientific — THINLINE ENDOCARDIAL PACING LEADS (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 19, 2025device pma362d agoBiotronik, Inc. — Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System (PMA supplement)OrphAI Therapeutics Inc

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoCooperVision, Inc. — up&up Monthly Performance + (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoABBOTT MEDICAL — TriClip G5 Delivery System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: NPS. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoCooperVision, Inc. — iWear oxygen presbyopia (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoMedtronic Minimed, Inc. — MiniMed 770G System (PMA supplement)Medtronic USA Inc

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoAdvanced Bionics — HiResolution™ Bionic Ear System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoOrganox Limited — OrganOx metra® System (PMA supplement)

    Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoStryker Neurovascular — Surpass Streamline Flow Diverter (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoCarl Zeiss Meditec Production, LLC — CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® AAA Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoMedtronic, Inc. — MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoABBOTT MEDICAL — MitraClip G5 Delivery System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: NKM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Aug 20, 2025device pma361d agoAtrium Medical Corp. — iCast Covered Stent System (PMA supplement)Apyx Medical Corp

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

    full page →fda device pma ↗
    ›Aug 21, 2025device pma360d agoSaluda Medical Pty, Ltd. — Saluda Medical Evoke SCS System (PMA supplement)

    Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Aug 21, 2025device pma360d agoDiaSorin, Inc. — LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 21, 2025device pma360d agoW. L. Gore & Associates, Inc. — GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 21, 2025device pma360d agoCarl Zeiss Meditec, Inc. — Visumax; VISUMAX 800 (PMA supplement)

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

    full page →fda device pma ↗
    $BSX51.83+0.27%
    $BSX51.83+0.27%
    $BSX51.83+0.27%
    $BSX51.83+0.27%
    $MDT91.27+0.76%
    $BSX51.83+0.27%
    $NPCE15.85-0.88%
    $BSX51.83+0.27%
    $A148.53-0.51%
    $MDT91.27+0.76%
    $IGC0.2670+0.41%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $APYX