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 | VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610 |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S108 |
Date Received | 08/30/2005 |
Decision Date | 12/07/2005 |
Product Code |
KRG |
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 VICTORY PULSE GENERATOR MODELS XL DR 5816, DR 5810 AND SR 5610. |
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