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calendar

1,490 catalysts · 4,728 grant · 3,603 8k filing · 2,621 approval · 2,129 device 510k · 1,725 device recall · 1,490 device pma

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type: device pma×from 2025-08-12×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,621
  • device 510k2,129
  • device recall1,725
  • device pma1,490
device adverse event
1,000
  • recall586
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Aug 11, 2025

    50
    ›Aug 12, 2025device pma384d 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 pma384d agoLenstec, 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 pma384d 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 ↗
    ›Aug 12, 2025device pma384d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1;Brav (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma383d agoMedtronic Vascular, Inc. — Protege™ RX Carotid Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma383d agoAvive Solutions, Inc. — Avive Automated External Defibrillator (AED) System (PMA supplement)Iveda Solutions, Inc.

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma383d agoBard Peripheral Vascular, Inc. — FLUENCY PLUS ENDOVASCULAR STENT GRAFT (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma383d agoEdwards Lifesciences, LLC — Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma383d agoZoll Manufacturing Corporation — LifeVest® Wearable Defibrillator, Model 4000 (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma382d 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 pma381d agoBiocartis Us, Inc. — Idylla CDx MSI Test (PMA)

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

    full page →fda device pma ↗
    ›Aug 15, 2025device pma381d 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 pma381d 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 pma381d 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 pma381d 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 pma381d 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 pma381d 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 ↗
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