Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX
• Generic Name: replacement Heart-valve
• Regulation Number: 870.3925
• Applicant: Edwards Lifesciences, LLC; One Edwards Way; Irvine, CA 92614
• PMA Number: P860057
• Supplement Number: S040
• Date Received: 10/02/2006
• Decision Date: 11/08/2006
• Product Code: DYE
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE TRADE NAME CHANGE FOR THREE DEVICES, THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX, THE CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2800TFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON RSR PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2800TFX, AND THE CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL MITRAL BIOPROSTHESIS MODEL 6900PTFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL MITRAL BIOPROSTHESIS MODEL 6900PTFX. THE INDICATIONS FOR THE THREE DEVICES REMAIN UNCHANGED.