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: VERSATRAX(TM) CARDIAC PACING SYSTEM
• 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: P820003
• Supplement Number: S053
• Date Received: 08/14/1990
• Decision Date: 05/08/1991
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No