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  3. ›device pma
device pma
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Medtronic, Inc. — Sphere-9 Catheter; Tubing Set; Extension Cable (PMA supplement)

April 2, 2026$MDTupdated 5mo ago
community read0 votes

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

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fda device pma
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same company · ±60 days · 6

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  • device adverse eventSELECTSECURE MRI SURESCAN — Injury eventMar 31, 2026
  • device pmaMedtronic — HeartWare HVAD System (PMA supplement)Apr 7, 2026

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