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device pma
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Medtronic, Inc. — SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (Drug Delivery Infusion Pump 8667) (PMA supplement)

February 6, 2026$MDTupdated 5mo ago
community read0 votes

Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

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fda device pma
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same company · ±60 days · 6

  • device pmaMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS, DBS Neurostimulator Implantable, DBS Neuros (PMA supplement)Feb 6, 2026
  • device pmaMedtronic, Inc. — Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron (PMA supplement)Feb 4, 2026
  • device pmaMedtronic, Inc. — Avalus™ Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus™ Ultra Bioprosthesis Model 400 (400U1 (PMA supplement)Feb 4, 2026
  • device pmaMedtronic — HeartWare® HVAD System (PMA supplement)Feb 3, 2026
  • device pmaMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Feb 10, 2026
  • device pmaMedtronic, Inc. — Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T (PMA supplement)Feb 10, 2026

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