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calendar

1,959 catalysts · 4,728 grant · 3,603 8k filing · 2,780 device 510k · 2,724 approval · 2,000 device recall · 1,959 device pma

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type: device pma×from 2025-06-03×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k2,780
  • approval2,724
  • device recall2,000
  • device pma1,959
device adverse event
1,000
  • recall693
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 2, 2025

    46
    ›Jun 3, 2025device pma454d agoBoston Scientific Corp — AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jun 3, 2025device pma454d agoInspire Medical Systems — Inspire Upper Airway Stimulation (UAS) (PMA supplement)Inspire Medical Systems, Inc.

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

    full page →fda device pma ↗
    ›Jun 3, 2025device pma454d agoInsightec — Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 3, 2025device pma454d agoCardiovascular Systems, Inc. — Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoBoston Scientific Corp — NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoNovocure, GmbH — Optune Lua (PMA supplement)NovoCure Ltd

    Supplement type: 30-Day Notice. Product code: SDA. Advisory committee: AN. Decision: OK30

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoMicro Therapeutics, Inc. d/b/a ev3 Neurovascular — Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoEdwards Lifesciences, LLC — EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE dilator kit: 9850DK EVOQUE loading system: 9850LS (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 ↗
    ›Jun 4, 2025device pma453d agoEdwards Lifesciences, LLC — PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoABBOTT MEDICAL — HeartMate II™ Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoEdwards Lifesciences, LLC — Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoMedtronic — HEARTWARE VENTRICULAR ASSIST SYSTEM (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoMedtronic, Inc. — OmniaSecure™ MRI SureScan™ Lead Model 3930M (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoCaris Life Sciences — MI Cancer Seek (PMA supplement)Caris Life Sciences, Inc.

    Supplement type: Real-Time Process. Product code: PQP. Advisory committee: MG. Decision: APPR

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoCentinel Spine, LLC — prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoCentinel Spine, LLC — PRODISC -L TOTAL DISC REPLACEMENT DEVICE (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoBoston Scientific — Endotak Lead System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoPramand, LLC — SpineSeal Spine Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoDiaSorin, Inc. — LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus (PMA supplement)

    Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoDiaSorin, Inc. — LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc (PMA supplement)

    Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma453d agoSiemens Corp. — ADVIA Centaur HBsAgII (HBsII) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LOM. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoW. L. Gore and Associates, Inc. — GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoW. L. Gore and Associates, Inc. — GORE EXCLUDER Conformable AAA Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoMedtronic, Inc. — CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d 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 ↗
    ›Jun 5, 2025device pma452d agoW. L. Gore & Associates, Inc. — GORE TAG Thoracic Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoMedtronic, Inc. — CapSureFix MRI Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DVPB3D1; Cobalt XT MRI ICD DDPA2D1; Cobalt XT MRI ICD DVPA2D1; Crome MRI ICD DDPC (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoNuvasive, Inc. — Simplify® Cervical Artificial Disc (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoW. L. Gore & Associates, Inc. — GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoCeramtec GmbH — Ceramic TRANSCEND® Hip Articulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoW. L. Gore & Associates, Inc. — Conformable GORE® TAG® Thoracic Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoBiosense Webster, Inc. — VARIPULSE Bi-Directional Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma452d agoMedtronic — HeartWare™ Ventricular Assist System (HVAD) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 6, 2025device pma451d agoSurmodics,Inc. — SurVeil Drug-Coated Balloon (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 6, 2025device pma451d agoNovocure, GmbH — Optune® (PMA supplement)NovoCure Ltd

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

    full page →fda device pma ↗
    ›Jun 6, 2025device pma451d agoEdwards Lifesciences, LLC — EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗

    Week of Jun 9, 2025

    4
    ›Jun 9, 2025device pma448d agoABBOTT MEDICAL — Liberta RC Deep Brain Stimulation Implantable Pulse Generator (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma
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    448d ago
    Philips Medical Systems — HeartStart FRx Defibrillator (861304) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma448d agoPhilips Medical Systems, Inc. — HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma448d agoABBOTT MEDICAL — Eterna Spinal Cord Stimulation Implantable Pulse Generator (PMA supplement)

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

    full page →fda device pma ↗
    $BSX46.84+0.36%
    $NVCR20.05+28.74%
    $EW91.33-2.47%
    $EW91.33-2.47%
    $INSP42.44+0.38%
    $BSX46.84+0.36%
    $CAI
    $MDT91.23+1.40%
    $BSX46.84+0.36%
    $EW91.33-2.47%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $NVCR20.05+28.74%
    $EW91.33-2.47%
    $MMSI90.49+1.06%
    $MDT91.23+1.40%
    $EW91.33-2.47%