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: BJORK-SHILEY CARDIAC VALVE
• Generic Name: HEART-VALVE, MECHANICAL
• Applicant: Shiley, Inc.; 17600 Gillette Ave.; P.O. Box 19503; Irvine, CA 92714
• PMA Number: P780008
• Supplement Number: S005
• Date Received: 10/26/1981
• Decision Date: 02/05/1982
• Product Code: LWQ
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No