Victory Models 5816, 5810, 5610; Zephyr Models 5820, 5826, 5620, 5626; Accent Models PM1110, PM1210, PM2110, PM2210; As
FDA premarket approval P880086/S269 · decided 2016-02-22
Approval details
- PMA number
- P880086
- Supplement
- S269
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Victory Models 5816, 5810, 5610; Zephyr Models 5820, 5826, 5620, 5626; Accent Models PM1110, PM1210, PM2110, PM2210; As
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-01-27
- Decision date
- 2016-02-22
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Changes to the final electrical test equipment.
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