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calendar

297 catalysts · 3,230 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 60 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device pma×from 2026-02-24×clear all
type
  • 8k filing3,230
  • grant1,368
  • device adverse event1,000
  • approval615
  • earnings582
  • device 510k476
device pma
297
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area

    no tagged catalysts yet

    Week of Feb 23, 2026

    49
    ›Feb 24, 2026device pma171d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma171d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Programming Systems A510, A511, A520, A521) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma171d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Programming Systems A510, A511, A520, A521) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma171d agoMedtronic Sofamor Danek USA, Inc. — INFUSE Bone Graft (PMA supplement)Medtronic USA Inc

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma171d 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 ↗
    ›Feb 24, 2026device pma171d agoMedtronic Sofamor Danek USA, Inc. — INFUSE Bone Graft/Medtronic Interbody Fusion Device (PMA supplement)Medtronic USA Inc

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma171d agoMedtronic, Inc. — INFUSE Bone Graft (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NPZ. Advisory committee: DE. Decision: OK30

    full page →fda device pma ↗
    ›Feb 24, 2026device pma171d agoETHICON, Inc. — ETHIZIA™ Hemostatic Patch (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma171d 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 ↗
    ›Feb 24, 2026device pma171d 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 ↗
    ›Feb 24, 2026device pma171d agoABBOTT MEDICAL — Amplatzer™ Amulet™ Left Atrial Appendage Occluder (Amulet) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma170d agoNovocure, GmbH — Optune Gio® (PMA supplement)NovoCure Ltd

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma170d 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 ↗
    ›Feb 25, 2026device pma170d 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 ↗
    ›Feb 25, 2026device pma170d agoABBOTT MEDICAL — TriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma170d agoIntegra Lifesciences Corp. — INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft Dermal Regenera (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma170d agoABBOTT MEDICAL — MitraClip™ G5 Delivery System (CDS0801-NT, CDS0801-NTW, CDS0801-XT, CDS0801-XTW) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma170d agoNovocure, GmbH — Optune Lua® (PMA supplement)NovoCure Ltd

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma170d agoBoston Scientific Corp — AMS 800™ Artificial Urinary Sphincter (AUS) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoMedtronic, Inc. — CoreValve EnVeo Pro Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX 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 ↗
    ›Feb 26, 2026device pma169d agoCardiovascular Systems, Inc. — Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoScibase AB — Nevisense (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoIntera Oncology — lntera 3000 Hepatic Artery Infusion Pump (PMA supplement)

    Supplement type: Real-Time Process. Product code: LKK. Advisory committee: HO. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoAlcon Laboratories, Inc. — Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoMicroTransponder, Inc. — Vivistim® Paired VNS System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: QPY. Advisory committee: PM. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoETHICON, Inc. — ETHIZIA Hemostatic Patch (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoKARL STORZ Endoscopy-America, Inc. — Photodynamic Diagnostic D-Light C (PDD) System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoSynergy Spine Solutions, Inc. — Synergy Disc (PMA)

    Product code: MJO. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoIntegra LifeSciences Corporation — DuraSeal Exact Spine Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoMedtronic, Inc. — Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoTeleflex Medical, LLC — MANTA™ Vascular Closure Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d 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 ↗
    ›Feb 27, 2026device pma168d agoIntegra LifeSciences Corporation — DuraSeal Dural Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoRoche Diagnostics Corp. — Elecsys total PSA assay (PMA supplement)CS DIAGNOSTICS CORP.

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoMedtronic Neuromodulation — Altaviva™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d 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 ↗
    ›Feb 27, 2026device pma168d agoRoche Diagnostics Corp. — Elecsys free PSA assay (PMA supplement)CS DIAGNOSTICS CORP.

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoABBOTT MEDICAL — Next Gen Patient System – CM1200 CardioMEMS HERO Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d 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 ↗
    ›Feb 27, 2026device pma168d agoMedtronic Vascular — Endurant™, Endurant™ II/lls Stent Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoMedtronic Vascular — Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoSymatese — Evolysse™ Smooth; Evolysse™ Form (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma168d 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 ↗
    ›Feb 27, 2026device pma168d 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 ↗
    ›Feb 28, 2026device pma167d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

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

    full page →fda device pma ↗

    Week of Mar 2, 2026

    1
    ›Mar 2, 2026device pma165d 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 ↗
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