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calendar

1,026 catalysts · 3,288 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma

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type: device pma×from 2025-10-21×clear all
type
  • 8k filing3,288
  • grant2,401
  • approval2,188
  • device 510k1,517
  • device recall1,123
  • device pma1,026
device adverse event
1,000
  • earnings584
  • recall391
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 20, 2025

    50
    ›Oct 21, 2025device pma297d agoCordis US Corporation — PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 21, 2025device pma297d agoMedtronic Neuromodulation — Altaviva™ Implantable Neurostimulator (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 21, 2025device pma297d agoBiotronik, Inc. — Astron Peripheral Self- Expanding Nitinol Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 21, 2025device pma297d agoBiotronik, Inc. — Pulsar-18 T3 Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 21, 2025device pma297d agoInspire Medical Systems — Inspire Upper Airway Stimulation (PMA supplement)Inspire Medical Systems, Inc.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoAbbott Vascular — RX Herculink Elite (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoBoston Scientific Corp — G124 MOMENTUM™ CRT-D, G125 MOMENTUM™ CRT-D, G126 MOMENTUM™ CRT-D, G128 MOMENTUM, G138 MOMENTUM™ X4 CRT-D, G140 INOGEN™ C (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoGuidant Corp. — U125 VALITUDE™ CRT-P,U128 VALITUDE™ X4 CRT-P,U225 VISIONIST™ CRT-P,U226 VISIONIST™ CRT-P,U228 VISIONIST™ X4 CRT-P (PMA supplement)Guident Corp.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoAbbott Vascular — RX Acculink (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoLife Technologies Corporation — Oncomine Dx Express Test (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoTransMedics, Inc. — Organ Care System™ (OCS™) Heart System (PMA supplement)TransMedics Group, Inc.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoABBOTT MEDICAL — Esprit BTK RX System; Esprit BTK OTW System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoBoston Scientific Corp — L100 ESSENTIO™ SR,L101 ESSENTIO™ DR,L121 ESSENTIO™ EL DR,L200 PROPONENT™ SR,L201 PROPONENT™ DR,L221 PROPONENT™ EL DR,L30 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoAbbott Vascular — XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine OTW) (PMA supplement)Postsurgical Therapeutics Inc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoMedtronic, Inc. — Medtronic Evolut™ PRO+ Delivery Catheter System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoBoston Scientific — L110 ESSENTIO™ MRI SR,L111 ESSENTIO™ MRI DR,L131 ESSENTIO™ MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoLimFlow, Inc. — LimFlow System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoCook Ireland, Ltd. — Zilver Flex® 35 Vascular Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoAbbott Vascular, Inc. — Absolute Pro Vascular (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (AAP) (PMA supplement)Lifeloc Technologies, Inc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoTransMedics, Inc. — Organ Care System™ (OCS™) Lung System (PMA supplement)TransMedics Group, Inc.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoBoston Scientific — D010 INOGEN™ MINI ICD VR, D011 INOGEN™ MINI ICD VR, D012 INOGEN™ MINI ICD DR, D013 INOGEN™ MINI ICD DR, D020 DYNAGEN™ MI (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (PMA supplement)Lifeloc Technologies, Inc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoTransMedics, Inc. — Organ Care System™ (OCS™) Liver (PMA supplement)TransMedics Group, Inc.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoBoston Scientific Corporation — A209 SICD Gen 2,A219 SICD MRI (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoInspire Medical Systems — Inspire® Upper Airway Stimulation (PMA supplement)Inspire Medical Systems, Inc.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoBoston Scientific — D010 INOGEN™ MINI ICD VR,D011 INOGEN™ MINI ICD VR,D012 INOGEN™ MINI ICD DR,D013 INOGEN™ MINI ICD DR,D020 DYNAGEN™ MINI I (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoQIAGEN GmbH — therascreen® PIK3CA RGQ PCR Kit (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: OWD. Advisory committee: MG. Decision: APPR

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoBoston Scientific Corp — G124 MOMENTUM™ CRT-D,G125 MOMENTUM™ CRT-D,G126 MOMENTUM™ CRT-D,G128 MOMENTUM,G138 MOMENTUM™ X4 CRT-D,G140 INOGEN™ CRT-D, (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis (PMA supplement)Lifeloc Technologies, Inc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma296d agoOn-X Life Technologies, Inc. — On-X Heart Valve; On-X Ascending Aortic Prosthesis (PMA supplement)Lifeloc Technologies, Inc

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoABBOTT MEDICAL — Amplatzer™ Muscular VSD Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoBoston Scientific Corporation — ENROUTE® Transcarotid Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoABBOTT MEDICAL — Amplatzer™ Duct Occluder; Amplatzer™ Duct Occluder II; Amplatzer Piccolo™ Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoMedtronic, Inc. — Mosaic Bioprosthesis, Models 305, 310 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoABBOTT MEDICAL — Amplatzer™ Amulet™ Left Atrial Appendage Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoMedtronic, Inc. — Freestyle Bioprosthesis, Models 995, 995CS, 995MS (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoMedtronic Vascular — Endurant II/IIs Stent Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d 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 ↗
    ›Oct 23, 2025device pma295d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoBiotronik Nro, Inc. — Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLock (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoMedtronic, Inc. — Melody™ 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 ↗
    ›Oct 23, 2025device pma295d agoABBOTT MEDICAL — Amplatzer™ Septal Occluder; Amplatzer™ Multi-Fenestrated Septal Occluder - Cribriform (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoABBOTT MEDICAL — Amplatzer™ PFO Occluder; Amplatzer™ Talisman™ PFO Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoMedtronic, Inc. — Hancock II Bioprosthesis, Models T505, T510 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d agoNovocure, GmbH — Optune Gio™ - Maxpoint Version 2.0 (PMA supplement)NovoCure Ltd

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

    full page →fda device pma ↗
    ›Oct 23, 2025device pma295d 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 ↗
    ›Oct 24, 2025device pma294d agoBoston Scientific Corp — ACUITY X4 Leads (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
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    $LCTC
    $BSX51.69+0.53%
    $MDT90.58-0.20%
    $GDNT
    $TMDX69.43-2.72%
    $BSX51.69+0.53%
    $TMDX69.43-2.72%
    $BSX51.69+0.53%
    $INSP42.44+0.38%
    $BSX51.69+0.53%
    $LCTC
    $TMDX69.43-2.72%
    $BSX51.69+0.53%
    $BSX51.69+0.53%
    $BSX51.69+0.53%
    $LCTC
    $INSP42.44+0.38%
    $LCTC
    $BSX51.69+0.53%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $NVCR20.05+28.74%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $BSX51.69+0.53%