Navitor Transcatheter Aortic Valve Implantation System
ABBOTT MEDICAL · Aortic valve, prosthesis, percutaneously delivered · Cardiovascular
Open FDA's page for this record- PMA number
- P190023
- Supplement number
- S033
- Applicant
- ABBOTT MEDICAL
- Street 1
- 177 County Rd. B E.
- City
- St. Paul
- State
- MN
- Zip
- 55117
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Trade name
- Navitor Transcatheter Aortic Valve Implantation System
- Product code
- NPT
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited review flag
- N
- Date received
- 2026-05-12
- Decision date
- 2026-10-29
- Decision code
- APPR
- Ao statement
- approval for modification of the sterilization process to terminal liquid sterilization (TLS) with glutaraldehyde.
- Harmonized identifiers (openFDA)
- Device name
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3012148004, 2015691, 3005941719, 3017298588, 2025587, 9612164, 3009380063, 3005012805, 2011171, 3010432890, 3007063218, 3012179728, 2135147, 3015287573, 3010421104, 3009420598, 3044156918, 3007113487, 3011894841, 9617601, 1721676, 1928237, 3008500478, 3002807314, 3014918977
- FEI number
- 3012148004, 2015691, 3017298588, 2025587, 3009380063, 3005012805, 2011171, 3010432890, 3002534070, 3007063218, 3012179728, 3002807111, 3015287573, 3010421104, 3009420598, 1713910, 3044156918, 3007113487, 3011894841, 1721676, 3002806434, 3005334138, 1928237, 3002807314, 3014918977