PMA P000007S042

Device: EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
Product code: DYE
Decision date: 2013-09-23
Generic name: replacement Heart-valve
Approval order statement: CHANGING THE SILICONE GASKET MATERIAL (SUPPLIED BY ST. GOBAIN) FOR THE 3.8 OZ. JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR ALL EDWARDS HEART VALVES.

Current openFDA PMA Record

Device: EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P000007
Supplement: S042
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2013-09-23
Decision code: OK30
Date received: 2013-08-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGING THE SILICONE GASKET MATERIAL (SUPPLIED BY ST. GOBAIN) FOR THE 3.8 OZ. JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR ALL EDWARDS HEART VALVES.