Navitor TAVI System
FDA premarket approval P190023/S019 · decided 2024-05-29
Approval details
- PMA number
- P190023
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Navitor TAVI System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-05-01
- Decision date
- 2024-05-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- an extension of the shelf-life of the fixed pericardial leaflet components from 6 months to 18 months
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