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: APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P880086
• Supplement Number: S045
• Date Received: 03/13/1998
• Decision Date: 09/04/1998
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, jarfalla, Sweden.