PMA P860057S028

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 6900,X
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S028
Product code: DYE
Decision date: 2005-05-20
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.

Current openFDA PMA Record#

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 6900,X
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S028
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2005-05-20
Decision code: OK30
Date received: 2005-04-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.