PMA P870077S002

Device: CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)
Applicant: Edwards Lifesciences, LLC
Product code: DYE
Decision date: 1996-12-06
Generic name: replacement Heart-valve
Approval order statement: ADDITIONAL MANUFACTURING FACILITY LOCATED AT BAXTER HEALTHCARE CORPORATION, EDWARDS CVS DIVISION, 1435 MCGAW AVE., IRVINE, CA 92714

Current openFDA PMA Record

Device: CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S002
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 1996-12-06
Decision code: APPR
Date received: 1995-10-30
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITIONAL MANUFACTURING FACILITY LOCATED AT BAXTER HEALTHCARE CORPORATION, EDWARDS CVS DIVISION, 1435 MCGAW AVE., IRVINE, CA 92714