PMA P870077S060

Current openFDA PMA Record

Device: CARPENTIER-EDEARDS DURAFLEX LOW PRESSURE PROCINE MITRAL BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S060
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2014-03-27
Decision code: OK30
Date received: 2014-02-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE.