Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MODEL 1256D META MV CARDIAC PULSE GENERATOR
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: cardiac pacing system
• Regulation Number: 870.3610
• Applicant: PACESETTER, INC.
• PMA Number: P900070
• Supplement Number: S020
• Date Received: 09/10/1997
• Decision Date: 10/07/1997
• Product Code: DXY [ Registered Establishments with DXY ]
• Advisory Committee: Cardiovascular
• Supplement Type: real-time process
• Supplement Reason: labeling change - minor
• 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.