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Heart-Valve, Non-Allograft Tissue — Edwards Lifesciences, LLC (PMA P150036)

Heart-Valve, Non-Allograft Tissue — Edwards Lifesciences, LLC (PMA P150036) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Heart-Valve, Non-Allograft Tissue; Applicant: Edwards Lifesciences, LLC; Clearance track: PMA.

Device nameHeart-Valve, Non-Allograft Tissue
ApplicantEdwards Lifesciences, LLC
Clearance trackPMA
Submission numberP150036
DecisionAPPR
Decision date2018-06-13
Date received2017-11-13
Product codeLWR
Device class3
Medical specialtyUnknown
Applicant locationCA
SourceopenFDA device

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