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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacing system
Regulation Number870.3610
PMA NumberP900070
Supplement NumberS020
Date Received09/10/1997
Decision Date10/07/1997
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-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.