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calendar

2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma

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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,387
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Sep 15, 2025

    43
    ›Sep 16, 2025device pma311d agoBoston Scientific — ACC SUP VEIN PICK (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoArj Medical, Inc. — PyloPlus Urea Breath Test System (PMA supplement)AVITA Medical, Inc.

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific — VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-coated 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 ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific — ACC SUP FIXATION TOOL (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific — ACC STY TPR 0.013 - Accessory Stylet Straight, X-Soft; ACC STY 0.014 SOFT LONG TPR - Accessory Stylet Long Taper, Soft; (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific Corp — CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific — ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxelcoated PTA Balloon Catheter; IN.PACT 018 Paclitaxel-coated 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 ↗
    ›Sep 17, 2025device pma310d agoABBOTT MEDICAL — Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201 (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 17, 2025device pma310d agoABBOTT MEDICAL — CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 17, 2025device pma310d agoDilon Medical Technologies, Ltd. — MarginProbe (PMA supplement)KESTRA MEDICAL TECHNOLOGIES, LTD.

    Supplement type: Normal 180 Day Track. Product code: OEE. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Sep 17, 2025device pma310d agoHowmedica Osteonics Corp. — Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 17, 2025device pma310d agoHeartsine Technologies, Ltd. — HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (PMA supplement)TAT TECHNOLOGIES LTD

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoMedtronic Neuromodulation — Medtronic Altaviva System (PMA)

    Product code: QPT. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS Neurostimulator Implantable B35200); (DBS Ne (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator 97800); (SNS Bowel Neurostimulators Impl (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoMicroVention, Inc. — FRED X System (PMA supplement)MICROVISION, INC.

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoSiemens Healthcare Diagnostics Products, Ltd. — IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoAlcon Laboratories, Inc. — AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoEndologix, LLC — DETOUR System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoABBOTT MEDICAL — Amplatzer™ Amulet™ Left Atrial Appendage Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoTeoxane S.A. — RHA® Dynamic Volume, RHA®4 (PMA supplement)

    Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoCook Medical Incorporated — ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator 97800); (SNS Urinary Neurostimulator I (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoAlcon Laboratories, LLC — Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoAlcon Research, Ltd. — AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (PMA supplement)Rubicon Research Ltd

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoMedtronic, Inc. — SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (Drug Delivery Infusion Pump 8667); (Drug Delivery Infusion (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoSiemens Healthcare Diagnostics Products, Ltd. — IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoMedtronic Neuromodulation — Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 18, 2025device pma309d agoSiemens Healthcare Diagnostics Products, Ltd. — IMMULITE 2000 Total Antibodies to Hepatitis B Surface Antigen (Anti-HBs) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoBoston Scientific Corp — Vercise Deep Brain Stimulation (DBS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoAbiomed, Inc. — Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoContego Medical, Inc. — Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection – (Neuroguard I (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoRoche Molecular Systems, Inc. — cobas HPV (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: MAQ. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoBoston Scientific Corp — Carotid Wallstent™ Monorail™ Endoprosthesis (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoIllumina, Inc. — TruSight Oncology Comprehensive (PMA supplement)ILLUMINA, INC.

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoOrganox Limited — OrganOx metra® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoRoche Molecular Systems, Inc. — cobas HBV (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: MKT. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 19, 2025device pma308d agoAbiomed, Inc. — Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Sep 20, 2025device pma307d agoMicroVention, Inc. — Flow Re-Direction Endoluminal Device (FRED) X System (PMA supplement)MICROVISION, INC.

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

    full page →fda device pma ↗

    Week of Sep 22, 2025

    7
    ›Sep 22, 2025device pma305d agoCooperVision, Inc. — Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 22, 2025device pma
    ← prev
    page 16 of 40
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    305d ago
    ZOLL Medical Corporation — CPR-D-padz Electrode (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 22, 2025device pma305d agoBoston Scientific — Accolade MRI Pacemakers, ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI ( (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 22, 2025device pma305d agoZOLL Medical Corporation — CPR Uni-padz Electrode (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 22, 2025device pma305d agoGuidant Corp. — Accolade Cardiac Resynchronization Therapy Pacemakers, VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Model (PMA supplement)Guident Corp.

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

    full page →fda device pma ↗
    ›Sep 22, 2025device pma305d agoABBOTT MEDICAL — Navitor Transcatheter Aortic Valve Implantation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 22, 2025device pma305d agoBoston Scientific Corp — Cardiac Resynchronization Therapy Defibrillators INOGEN (Models G140, G141, G146, G148); DYNAGEN (Models G150, G151, G15 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $RCEL4.6100-6.68%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $KMTS20.35+8.13%
    $MDT82.01+0.15%
    $TATT
    $MDT82.01+0.15%
    $MDT82.01+0.15%
    $MVIS0.2753-8.17%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $ILMN196.86+3.14%
    $MDT82.01+0.15%
    $MVIS0.2753-8.17%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $GDNT
    $BSX43.58+1.42%