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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.
 
Trade NameTEMPO DR 2102 AND TEMP D 2902
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacing system
Regulation Number870.3610
ApplicantTELECTRONICS PACING SYSTEMS, INC.
PMA NumberP900070
Supplement NumberS015
Date Received11/06/1996
Decision Date11/27/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification to the labeling regarding the proper insertion of a lead into the connector port.
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