PorticoTM, NavitorTM, and Navitor Titan Transcatheter Aortic Heart Valves
FDA premarket approval P190023/S016 · decided 2023-11-07
Approval details
- PMA number
- P190023
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PorticoTM, NavitorTM, and Navitor Titan Transcatheter Aortic Heart Valves
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-10-02
- Decision date
- 2023-11-07
- Days to decision
- 36 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- two new abattoirs as tissue suppliers and one new source country for collecting bovine pericardial tissue for the Portico, Navitor, and Navitor Titan valves
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
| Amplatzer TorqVue Exchange System (K261631) | Abbott Medical | 2026-06-17 |
| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
| Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499) | ABBOTT MEDICAL | 2026-03-13 |
| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |