PMA P860057S030

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S030
Product code: DYE
Decision date: 2005-10-07
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.

Current openFDA PMA Record#

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S030
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2005-10-07
Decision code: APPR
Date received: 2005-08-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.