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: MODEL 1256D META MV CARDIAC PULSE GENERATOR
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 Valley View Ct.; Sylmar, CA 91342
• PMA Number: P900070
• Supplement Number: S020
• Date Received: 09/10/1997
• Decision Date: 10/07/1997
• Withdrawal Date: 06/20/2007
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: Real-Time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for the change in companies from Telectronics to Pacesetter. The device, as modified, will be marketed under the brand name Pacesetter for the dual chamber pacing models of the META(TM) DDDR Model 1250H Pulse Generator (hereinafter referred to as the META(TM) DDDR) which is indicated where maintenance of atrio-ventricular synchrony is required. This requirement is associated with the generally accepted indication for permanaent cardiac pacing which includes, but are not limited to: 1) sick sinus node syndorme; 2)symptomatic bradycardia; 3)symptomatic A-V block; 4)recurrent Stokes-Adams syndrome; 5)carotid sinus syncope; and 6)suppression of tachycardia.