PMA P870077S056

Device: CARTENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING
Applicant: Edwards Lifesciences, LLC
Product code: DYE
Decision date: 2013-10-11
Generic name: replacement Heart-valve
Approval order statement: ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.

Current openFDA PMA Record

Device: CARTENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S056
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2013-10-11
Decision code: OK30
Date received: 2013-09-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.