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Replacement Heart-Valve — Medtronic, Inc. (PMA P990064)

Replacement Heart-Valve — Medtronic, Inc. (PMA P990064) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Replacement Heart-Valve; Applicant: Medtronic, Inc.; Clearance track: PMA.

Device nameReplacement Heart-Valve
ApplicantMedtronic, Inc.
Clearance trackPMA
Submission numberP990064
DecisionAPPR
Decision date2026-03-03
Date received2025-09-04
Product codeDYE
Device class3
Medical specialtyCardiovascular
Applicant locationCA
SourceopenFDA device

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