Navitor Transcatheter Aortic Valve Implantation (TAVI) System
FDA premarket approval P190023/S024 · decided 2025-01-06
Approval details
- PMA number
- P190023
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-12-06
- Decision date
- 2025-01-06
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- approval for changes to the Instructions for Use distributed with the Navitor TAVI System and with the Navitor with Vision Technology TAVI System
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510(k) clearances by this applicant
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|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |