IsoFlex Optim
FDA premarket approval P960030/S075 · decided 2021-07-07
Approval details
- PMA number
- P960030
- Supplement
- S075
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IsoFlex Optim
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-06-28
- Decision date
- 2021-07-07
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Adjust Bioburden action limit and alert levels at the Sylmar manufacturing site.
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