PMA P010041S018

Current openFDA PMA Record

Device: CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P010041
Supplement: S018
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2008-12-17
Decision code: OK30
Date received: 2008-11-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITIONAL SUPPLIER FOR SEWING THREAD TWISTING.