FORTIFY VR DF-4 FAMILY OF ICDS
FDA premarket approval P910023/S299 · decided 2012-08-22
Approval details
- PMA number
- P910023
- Supplement
- S299
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FORTIFY VR DF-4 FAMILY OF ICDS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-07-27
- Decision date
- 2012-08-22
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGE TO THE TOOLING USED DURING THE ROUTING STEP OF THE MANUFACTURING PROCESS FOR THE FEEDTHRU.
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