ATLAS II + HF CRT-D SYSTEM
FDA premarket approval P030054/S067 · decided 2009-01-13
Approval details
- PMA number
- P030054
- Supplement
- S067
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATLAS II + HF CRT-D SYSTEM
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-09-05
- Decision date
- 2009-01-13
- Days to decision
- 496 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- 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.
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