PMA P870077S037

Current openFDA PMA Record

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S037
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2010-12-22
Decision code: OK30
Date received: 2010-11-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.