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: BYREL PROGRAMABLE PACEMAKER
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P780009
• Supplement Number: S001
• Date Received: 06/12/1981
• Decision Date: 07/21/1981
• Withdrawal Date: 04/14/2008
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No