PMA P870077S010

Device: CARPENTIER EDWARDS DURAFLEX BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
Product code: DYE
Decision date: 1999-10-22
Generic name: replacement Heart-valve
Approval order statement: The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves. The change will allow for parametric release following terminal liquid sterilization in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process.

Current openFDA PMA Record

Device: CARPENTIER EDWARDS DURAFLEX BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S010
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 1999-10-22
Decision code: OK30
Date received: 1999-10-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves. The change will allow for parametric release following terminal liquid sterilization in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process.