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Replacement Heart-Valve — Edwards Lifesciences, LLC (PMA P860057)

Replacement Heart-Valve — Edwards Lifesciences, LLC (PMA P860057) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Replacement Heart-Valve; Applicant: Edwards Lifesciences, LLC; Clearance track: PMA.

Device nameReplacement Heart-Valve
ApplicantEdwards Lifesciences, LLC
Clearance trackPMA
Submission numberP860057
DecisionAPPR
Decision date2004-12-29
Date received2004-09-27
Product codeDYE
Device class3
Medical specialtyCardiovascular
Applicant locationCA
SourceopenFDA device

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