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 | ADVISA DR IPG, AT501 DDDRP PACING SYSTEM IPG |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S272 |
Date Received | 08/21/2012 |
Decision Date | 03/26/2013 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST-APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES. |
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