IDENTITY, SUSTAINXL, VERITY VICTORY ZEPHYR, ACCENT FAMILIES OF PACEMAKER DEVICE
FDA premarket approval P880086/S239 · decided 2014-03-04
Approval details
- PMA number
- P880086
- Supplement
- S239
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IDENTITY, SUSTAINXL, VERITY VICTORY ZEPHYR, ACCENT FAMILIES OF PACEMAKER DEVICE
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-02-05
- Decision date
- 2014-03-04
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGE IN THE WIRE BOND PROCESS VERIFICATION FREQUENCY UTILIZED FOR THE HYBRID ASSEMBLIES OF THE DEVICES.
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