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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
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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