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 | ATLAS II + HF CRT-D SYSTEM |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S067 |
Date Received | 09/05/2007 |
Decision Date | 01/13/2009 |
Product Code |
NIK |
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 ST. JUDE MEDICAL SJ4 QUADRIPOLAR DEFIBRILLATION SYSTEMCONSISTING OF DEVICE MODELS ATLAS II+HF V366Q AND PROMOTE 3107-36Q; LEAD MODELS RIATA STOPTIM 7020Q, 7021Q, 7022Q, AND RIATA STS OPTIM 7120Q, 7121Q, 7122Q; AND PROGRAMMER MODELS SJM 3510 AND MERLIN 3650. |
Post-Approval Study | Show Report Schedule and Study Progress |
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