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 Mechanical heart Valves
• Generic Name: HEART-VALVE, MECHANICAL
• Applicant: ABBOTT MEDICAL; 177 County Rd. B E.; St. Paul, MN 55117
• PMA Number: P810002
• Supplement Number: S103
• Date Received: 07/19/2017
• Decision Date: 08/10/2017
• Product Code: LWQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Modifications to the cleanroom area including introduction of new equipment.