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. |
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Device | TEMPO DR 2102 AND TEMP D 2902 |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 Valley View Ct. Sylmar, CA 91342 |
PMA Number | P900070 |
Supplement Number | S014 |
Date Received | 09/16/1996 |
Decision Date | 08/27/1997 |
Withdrawal Date
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06/20/2007 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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