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: MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: St. Jude Medical, Inc.; 15900 Valley View Ct.; Sylmar, CA 91342
• PMA Number: P830045
• Supplement Number: S005
• Date Received: 09/28/1984
• Decision Date: 11/16/1984
• Withdrawal Date: 06/20/2007
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No