PMA P870077S046

Current openFDA PMA Record

Device: CAPENTIER-EDWARDS S.A.V. BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S046
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2012-09-19
Decision code: OK30
Date received: 2012-08-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.