PMA P860057S053

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S053
Product code: DYE
Decision date: 2009-12-08
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: APPROVAL FOR HARMONIZING THE CENTRAL HOLE DIAMETER, HARMONIZING THE WIREFORM CUSP DIAMETER AND ADDING AORTIC COMMISSURE TIP ANGLE AND COMMISSURE TIP RADIUS INSPECTIONS.

Current openFDA PMA Record#

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S053
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2009-12-08
Decision code: APPR
Date received: 2008-12-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR HARMONIZING THE CENTRAL HOLE DIAMETER, HARMONIZING THE WIREFORM CUSP DIAMETER AND ADDING AORTIC COMMISSURE TIP ANGLE AND COMMISSURE TIP RADIUS INSPECTIONS.