AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
FDA premarket approval P880086/S209 · decided 2011-09-28
Approval details
- PMA number
- P880086
- Supplement
- S209
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-08-31
- Decision date
- 2011-09-28
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
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