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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 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.
 
DeviceTEMPO DR 2102 AND TEMP D 2902
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP900070
Supplement NumberS014
Date Received09/16/1996
Decision Date08/27/1997
Withdrawal Date 06/20/2007
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Tempo DR Model 2102, Tempo D Model 2902, Tempo VR Model 1102, and Tempo V Model 1902 Pulse Generators.
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