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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Feb 9, 2026

    50
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01); Astra S DR MRI IPG (X3DR01); Astra S SR (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — Harmony™ Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoBoston Scientific Corporation — TheraSphere (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Panel Track. Product code: NAW. Advisory committee: RA. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: Panel Track. Product code: PLS. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d 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 ↗
    ›Feb 10, 2026device pma166d agoContamac, Ltd. — Optimum Infinite (tisilfocon A) Orthokeratology Lenses II (PMA)

    Product code: NUU. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic Cardiac Rhythm Disease Management — CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoABBOTT MEDICAL — Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoCooperVision, Inc. — Biofinity Sphere and Biofinity 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 ↗
    ›Feb 10, 2026device pma166d agoAbbott Vascular, Inc. — Perclose™ ProGlide Suture-Mediated Closure System; Perclose™ ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoABBOTT MEDICAL — Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d 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 ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — HV Splitter/Adaptor kit 5019 IS-1 Connector Port Pin Plug Kit 6725 Sprint Quattro Lead 6935, 6947 Sprint Quattro Lead 69 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDR06, ADDRL1, ADSR03, ADVDD01, SED01, SES01, VEDR01); Adapta, Versa, Sensia (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — Attain StarFix Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d 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 ↗
    ›Feb 10, 2026device pma166d agoAlcon Research, LLC — UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System (PMA supplement)

    Supplement type: Real-Time Process. Product code: LPO. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — CapSure VDD-2 Lead 5038, 5038L, 5038S Service Kit-Pacemaker Repair Kit 5873C Vitatron Brilliant S+ VDD Lead IMW14Q, IMW1 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic Cardiac Rhythm Disease Management — CapSure SP Novus Lead 5092 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 ↗
    ›Feb 11, 2026device pma165d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoFerrosan Meidcal Devices A/S — SURGIFOAM® Absorbable Gelatin Sponge (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoBiotronik, Inc. — TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoBiotronik, Inc. — DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems Introducer Hub Mold Change (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic, Inc. — Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoBiotronik, Inc. — PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoAbbott Vascular, Inc. — Perclose ProGuide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic, Inc. — Harmony™ Delivery Catheter System (HARMONY-DCS) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic, Inc. — Aurora EV ICD (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoNovocure, GmbH — Optune Pax (PMA)NovoCure Ltd

    Product code: SHC. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoEdwards Lifesciences, LLC — Edwards EVOQUE Loading System (9850LSA); Edwards EVOQUE Loading System and Trimmer (9850LSB) (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic Neuromodulation — Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® S (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoUromedica, Inc. — ProACT Adjustable Continence Therapy for Men (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoRenata Medical, Inc. — Minima Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoBiotronik, Inc. — PHYLAX AV ICD SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoABBOTT MEDICAL — 8-channel adapter, M, 10cm; 8-channel adapter, M, 60cm; 8-channel adapter, B, 10cm; 8-channel adapter, B, 60cm; Legacy M (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic Vascular, Inc. — EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic Vascular, Inc. — Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoABBOTT MEDICAL — 8CH Infinity™ DBS Lead Kit, 30cm, 0.5, B; 8CH Infinity™ DBS Lead Kit, 30cm, 1.5, B; 8CH Infinity™ DBS Lead Kit, 40cm, 0 (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic, Inc. — EnVeo PRO Delivery Catheter System (ENVPRO-16-US), Evolut PRO+ Delivery Catheter System (D-EVPROP2329US, D-EVPROP34US), (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; Mirro (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 11, 2026device pma165d 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 ↗
    ›Feb 11, 2026device pma165d agoBoston Scientific Corporation — AGENT Paclitaxel-Coated Balloon Catheter (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
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    $MDT83.21+1.46%
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    $MDT83.21+1.46%
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