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: CORDIS SEQUICOR THETA MODELS 233D & 233E
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Telectronics Pacing Systems, Inc.; 7400 S. Tucson Way; Englewood, CO 80112
• PMA Number: P820014
• Supplement Number: S014
• Date Received: 12/31/1984
• Decision Date: 04/09/1985
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No