AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
FDA premarket approval P880086/S242 · decided 2014-05-29
Approval details
- PMA number
- P880086
- Supplement
- S242
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-04-15
- Decision date
- 2014-05-29
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650.
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