PMA P190023S010
- Device
- PorticoTM Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S010
- Product code
- NPT
- Decision date
- 2022-11-09
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for modifications to the packaging design for the FlexNav Delivery System.
Current openFDA PMA Record#
- Device
- PorticoTM Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S010
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-11-09
- Decision code
- APPR
- Date received
- 2022-08-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the packaging design for the FlexNav Delivery System.