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calendar

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 Mar 30, 2026

    7
    ›Apr 3, 2026device pma115d agoNeuspera Medical, Inc. — Neuspera Sacral Neuromodulation (SNM) System (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 3, 2026device pma115d agoABBOTT MEDICAL — AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 3, 2026device pma115d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Implantable Neurostimulators 97800, 97810) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 3, 2026device pma115d 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 ↗
    ›Apr 3, 2026device pma115d agoMedtronic Neuromodulation — Master Intellis , Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems (SCS Implantable Neurostimulators 97716, 97715, 9 (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 3, 2026device pma115d agoMedtronic Neuromodulation — Altaviva™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 3, 2026device pma115d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Implantable Neurostimulators 97800, 97810) (PMA supplement)

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

    full page →fda device pma ↗

    Week of Apr 6, 2026

    43
    ›Apr 7, 2026device pma111d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® FORTEGRA Venous Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 7, 2026device pma
    ← prev
    page 40 of 40
    next →
    111d ago
    Medtronic — HeartWare HVAD System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Apr 7, 2026device pma111d agoCerapedics, LLC — i-FACTOR® Peptide Enhanced Graft Substitute (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 7, 2026device pma111d agoCerapedics, Inc. — PearlMatrix™ Peptide Enhanced Bone Graft (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 7, 2026device pma111d agoAbiomed, Inc. — Impella 5.5 with Smart Assist (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Apr 7, 2026device pma111d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 7, 2026device pma111d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 7, 2026device pma111d agoTeoxane S.A. — RHA 2, RHA 3, RHA 4 (PMA supplement)

    Supplement type: Real-Time Process. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Apr 8, 2026device pma110d agoGlaukos Corporation — iStent® Trabecular Micro-Bypass Stent System (PMA supplement)GLAUKOS Corp

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

    full page →fda device pma ↗
    ›Apr 8, 2026device pma110d agoMedtronic Vascular, Inc. — Abre™ Venous Self-expanding Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 8, 2026device pma110d agoEmpirical Spine, Inc. — LimiFlex™ Dynamic Sagittal Tether (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoSynergy Spine Solutions, Inc. — Synergy Disc (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoAsahi Kasei Medical Co., Ltd. — Plasmaflo OP-05 W(A) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoMedtronic, Inc. — Avalus Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoEv3 Neurovascular — Apollo™ Onyx™ Delivery Micro Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoAdvanced Bionics — HiResolution™ Bionic Ear System Ultra and Ultra 3D Thin PCB (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoNovocure, GmbH — Optune HFE Transducer Array Soft Part Components (PMA supplement)NovoCure Ltd

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoCooperVision, Inc. — Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoSeikagaku Corp. — GEL-ONE (PMA supplement)Seikagaku Corp

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoMedtronic, Inc. — Melody Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoBoston Scientific Corp — Rotablator™; ROTAPRO™ Rotational Atherectomy Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 9, 2026device pma109d agoABBOTT MEDICAL — FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific — Lead Port Plug Model 6996 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoZoll Circulation, Inc. — TherOx Downstream System (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoAutoGenomics, Inc. — AvertD and AvertD Buccal Sample Collection Kit (PMA supplement)NEOGENOMICS INC

    Supplement type: Real-Time Process. Product code: QZH. Advisory committee: TX. Decision: APPR

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific Corp — Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific — Wrench Kit Model 6501 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific — Vein Pick Model 6541 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific Corporation — TheraSphere™ (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoDePuy Orthopaedics, Inc. — Ceramax Ceramic Hip System (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific — • Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 • Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific — Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoMedtronic — HEARTWARE VENTRICULAR ASSIST SYSTEM (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific — • ACUITY X4 Connector Tool Model 4625 • AICD Lead Stylets Firm Model 6971 • AICD Lead Stylets Soft Model 6972 • Suture S (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoBoston Scientific — Fixation Tool Model 6616 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoImpulse Dynamics (Usa), Inc. — GUARDIO/VESTA Charger (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoOrganox Limited — OrganOx metra® System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Apr 10, 2026device pma108d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

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

    full page →fda device pma ↗
    $MDT83.21+1.46%
    $GKOS153.58+0.95%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $NVCR20.05+28.74%
    $BSX44.25+1.54%
    $MDT83.21+1.46%
    $BSX44.25+1.54%
    $EW91.33-2.47%
    $BSX44.25+1.54%
    $EW91.33-2.47%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $NEO14.73+3.44%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $MDT83.21+1.46%
    $BSX44.25+1.54%
    $EW91.33-2.47%
    $BSX44.25+1.54%