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calendar

950 catalysts · 3,350 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event

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type: device pma×from 2025-10-29×clear all
type
  • 8k filing3,350
  • grant2,401
  • approval2,076
  • device 510k1,436
  • device recall1,072
  • device adverse event1,000
device pma
950
  • earnings584
  • recall376
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 27, 2025

    20
    ›Oct 29, 2025device pma291d agoPremia Spine, Ltd. — TOPS™ System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 29, 2025device pma291d agoBoston Scientific Corporation — SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 29, 2025device pma291d agoHighridge Medical, LLC — LDR Spine Mobi-C® Cervical Disc Prosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 29, 2025device pma291d agoBiotronik, Inc. — Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira SD 65/18 4 (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 29, 2025device pma291d agoZoll Circulation, Inc. — TherOx Downstream System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 29, 2025device pma291d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Scoreflex NC Scoring PTCA Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 29, 2025device pma291d 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 ↗
    ›Oct 29, 2025device pma291d agoVascutek, Ltd. — Thoraflex™ Hybrid (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 29, 2025device pma291d agoHighridge Medical, LLC — LDR Spine Mobi-C® Cervical Disc Prosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma290d agoMedtronic, Inc. — SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma290d agoSiemens Medical Solutions Diagnostics Limited — IMMULITE 2000 Free PSA (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma290d agoABBOTT MEDICAL — TactiFlex™ Ablation Catheter, Sensor Enabled ™ (TactiFlex SE) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma290d 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 ↗
    ›Oct 30, 2025device pma290d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

    Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30

    full page →fda device pma ↗
    ›Oct 30, 2025device pma290d 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 ↗
    ›Oct 30, 2025device pma290d agoSiemens Healthcare Diagnostics, Inc. — IMMULITE 2000 AFP (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma290d agoABBOTT MEDICAL — Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra and Epic™ Max Stented Tissue Valve (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma290d agoSiemens Healthcare Diagnostics, Inc. — IMMULITE 2000 PSA (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 31, 2025device pma289d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Nov 2, 2025device pma287d agoMicroVention, Inc. — Flow Re-Direction Endoluminal Device (FRED®) 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 Nov 3, 2025

    21
    ›Nov 3, 2025device pma286d agoBeckman Coulter, Inc. — Access AFP (on DxI 9000 Analyzer) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LOK. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    ›Nov 4, 2025device pma

    Week of Nov 10, 2025

    9
    ›Nov 10, 2025device pma279d agoMedtronic, Inc. — Hancock II Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma
    ← prev
    page 1 of 19
    next →
    285d ago
    Q-Med AB — Restylane® Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma285d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma285d agoMedtronic Neuromodulation — nterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma285d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma285d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (LVAS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma285d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma285d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 5, 2025device pma284d agoPromega Corporation — OncoMate® MSI Dx Analysis System (PMA)

    Product code: SFL. Advisory committee: MG. Decision: APPR

    full page →fda device pma ↗
    ›Nov 6, 2025device pma283d agoNyxoah S.A. — Genio® System 2.1 (PMA supplement)Nyxoah SA

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma283d agoStryker Leibinger GmbH & Co KG — Adherus AutoSpray Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma283d agoPhysio-Control, Inc. — LIFEPAK® CR2 Automated External Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma283d agoBoston Scientific Corp — WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma282d agoABBOTT MEDICAL — Dorsal Root Ganglion (DRG) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma282d agoABBOTT MEDICAL — Spinal Cord Stimulation (SCS) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma282d 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 ↗
    ›Nov 7, 2025device pma282d agoMedtronic Vascular, Inc. — EverFlex self-expanding Peripheral Stent System (EverFlex) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma282d agoIntersect Ent. — Propel Contour Sinus Implant (PMA supplement)

    Supplement type: Real-Time Process. Product code: OWO. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Nov 7, 2025device pma282d agoABBOTT MEDICAL — Deep Brain Stimulation (DBS) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma282d agoMedtronic Vascular, Inc. — Protégé GPS self-expanding Peripheral Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 8, 2025device pma281d agoSaluda Medical Pty, Ltd. — Saluda Medical Evoke® SCS System (PMA supplement)

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

    full page →fda device pma ↗
    279d ago
    ABBOTT MEDICAL — CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma279d agoMedtronic, Inc. — Freestyle Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma279d agoMedtronic, Inc. — Mosaic Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma279d agoMedtronic, Inc. — Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 12, 2025device pma277d agoGraphic Controls D.B.A. Vermed — HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 13, 2025device pma276d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 13, 2025device pma276d agoMedtronic, Inc. — SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track. Product code: LKK. Advisory committee: HO. Decision: APPR

    full page →fda device pma ↗
    ›Nov 13, 2025device pma276d agoBaxter Healthcare Corp — Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (PMA supplement)Baxter Healthcare Corp

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

    full page →fda device pma ↗
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $NYXH
    $MDT91.27+0.76%
    $MVIS2.2350-40.72%
    $MDT91.27+0.76%
    $EW91.33-2.47%
    $GH131.78+2.07%
    $MDT91.27+0.76%
    $BSX51.83+0.27%
    $MDT91.27+0.76%
    $BSX51.83+0.27%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%