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calendar

1,679 catalysts · 4,728 grant · 3,603 8k filing · 2,674 approval · 2,394 device 510k · 1,898 device recall · 1,679 device pma

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type: device pma×from 2025-07-11×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,674
  • device 510k2,394
  • device recall1,898
  • device pma1,679
device adverse event
1,000
  • recall623
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jul 7, 2025

    14
    ›Jul 11, 2025device pma415d agoCordis US Corporation — EXOSEAL Vascular Closure Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoVentana Medical Systems, Inc. (Roche Tissue Diagnostics) — VENTANA MET (SP44) RxDx Assay (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoAbbott Diabetes Care, Inc. — FreeStyle Libre Pro Flash Glucose Monitoring System (PMA supplement)TANDEM DIABETES CARE INC

    Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoEdwards Lifesciences, LLC — PASCAL Precision Transcatheter Valve Repair System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoBoston Scientific — ESSENTIO™ MRI (Models L110, L111, L131); PROPONENT™ MRI (Models L210, L211, L231); ACCOLADE™ MRI (Models L310, L311, L33 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoAbbott Diabetes Care, Inc. — FreeStyle Libre 14-Day Flash Glucose Monitoring System (PMA supplement)TANDEM DIABETES CARE INC

    Supplement type: 30-Day Notice. Product code: PZE. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoZOLL Medical Corporation — AED Plus and Fully Automatic AED Plus (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoBoston Scientific Corp — ALTRUA™ 2 (Models S701, S702, S722); ESSENTIO™ (Models L100, L101, L121); PROPONENT™ (Models L200, L201, L221); ACCOLADE (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoGuidant Corp. — VALITUDE™ (Model U125); VALITUDE™ X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST™ X4 (Model U228) (PMA supplement)Guident Corp.

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoCvrx, Inc. — BAROSTIM NEO® System (PMA supplement)CVRx, Inc.

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoZOLL Medical Corporation — X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoMedtimo, Inc. — ReShape Lap-Band System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (LVAS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 11, 2025device pma415d agoBoston Scientific Corporation — Orbera® Intragastric Balloon (IGB) System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗

    Week of Jul 14, 2025

    36
    ›Jul 14, 2025device pma412d 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 ↗
    ›Jul 14, 2025device pma
    ← prev
    page 1 of 34
    next →
    412d ago
    Boston Scientific Corp — AMS 700 Inflatable Penile Prosthesis (IPP) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jul 14, 2025device pma412d agoRxsight, Inc. — RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) (PMA supplement)RxSight, Inc.

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

    full page →fda device pma ↗
    ›Jul 14, 2025device pma412d agoCooperVision, Inc. — Biofinity XR Toric (comfilcon A) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 14, 2025device pma412d agoAllergan — Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra, Ultra XC and Ultra Plus X (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 14, 2025device pma412d agoBoston Scientific Corp — AMS 800 Artificial Urinary Sphincter (AUS) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jul 14, 2025device pma412d agoMerz North America, Inc. — RADIESSE (+) Lidocaine (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Jul 15, 2025device pma411d agoMedtronic, Inc. — SmartSync™ Pacing System Analyzer (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track. Product code: NVZ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jul 15, 2025device pma411d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 15, 2025device pma411d agoImpulse Dynamics (Usa), Inc. — OPTIMIZER Smart System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 15, 2025device pma411d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DVPA2D1); Cobalt XT MRI ICD (DDPA2D4, D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 15, 2025device pma411d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) 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 ↗
    ›Jul 15, 2025device pma411d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI, CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 15, 2025device pma411d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoMedtronic Neuromodulation — Restore; Itrel; Synergy Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Vectris Sp (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d 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 ↗
    ›Jul 16, 2025device pma410d agoMedtronic Cardiac Rhythm Disease Management — CapSure SP Z Lead 5033; Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoZoll Manufacturing Corporation — LifeVest® Wearable Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoBiotronik, Inc. — Astron (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoMedtronic, Inc. — CapSure Epicardial Pacing Lead 4965; CapSure Epicardial Pacing Lead 4968 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoBoston Scientific Corp — WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Panel Track. Product code: NGV. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoSiemens Healthcare Diagnostics, Inc. — ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoSiemens Healthcare Diagnostics — ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoW. L. Gore & Associates, Inc. — GORE® TAG® Conformable Thoracic Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d 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 ↗
    ›Jul 16, 2025device pma410d agoValencia Technologies Corporation — eCoin Peripheral Neurostimulator (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoMedtronic, Inc. — CapSureFix Novus Lead 5076; Vitatron Crystalline ActFix Lead ICF09B (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoSiemens Healthcare Diagnostics — ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoMedtronic, Inc. — print Quattro Lead 6935M; Sprint Quattro Lead 6947M; Sprint Quattro Lead 6947; Sprint Quattro Lead 6935 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d agoMedtronic, Inc. — CapSure VDD-2 Lead 5038, 5038L, 5038S; Vitatron Brilliant S+ VDD Lead IMW14Q, IMW15Q, IMW16Q; Vitatron Brilliant S+VDD L (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 16, 2025device pma410d 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 ↗
    ›Jul 16, 2025device pma410d agoZoll Manufacturing Corporation — WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 17, 2025device pma409d agoABBOTT MEDICAL — HeartMate II Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 17, 2025device pma409d 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 ↗
    ›Jul 17, 2025device pma409d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 17, 2025device pma409d 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 ↗
    $TNDM21.43+0.14%
    $GDNT
    $BSX46.84+0.36%
    $BSX46.84+0.36%
    $EW91.33-2.47%
    $CVRX
    $TNDM21.43+0.14%
    $BSX46.84+0.36%
    $RXST
    $BSX46.84+0.36%
    $BSX46.84+0.36%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $BSX46.84+0.36%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%