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: RX5000 PROGRAMMER
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P830026
• Supplement Number: S075
• Date Received: 09/07/1999
• Decision Date: 09/24/1999
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Express GMP Supplement
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a manufacturing site located at Benchmark Electronics, 4065 Theurer Blvd., Winona, MN 55987.