Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS
• Classification Name: replacement heart-valve
• Generic Name: bioprosthetic valved conduit
• Regulation Number: 870.3925
• Applicant: EDWARDS LIFESCIENCES, LLC.
• PMA Number: P870056
• Supplement Number: S051
• Date Received: 08/21/2012
• Decision Date: 09/19/2012
• Product Code: DYE [ Registered Establishments with DYE ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Modify the layout of an isolation clean room.