Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: BYREL PROGRAMABLE PACEMAKER
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P780009
• Date Received: 11/20/1978
• Decision Date: 03/27/1979
• Withdrawal Date: 04/14/2008
• Product Code: LWP
• Notice Date: 08/03/1979
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001