device pma

Medtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (HexaFlow Irrigation Pump; HexaGen RF Generator; HexaPulse PF Generator) (PMA supplement)

July 22, 2025$MDTupdated 2mo ago

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

Medtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (HexaFlow Irrigation Pump; HexaGen RF Generator; HexaPulse PF Generator) (PMA supplement)