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: ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES
• Generic Name: heart-valve, non-allograft tissue
• Applicant: ABBOTT MEDICAL; 177 County Rd. B E.; St. Paul, MN 55117
• PMA Number: P040021
• Supplement Number: S022
• Date Received: 04/17/2012
• Decision Date: 08/30/2012
• Product Code: LWR
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.