PMA P190023S009
- Device
- Portico™ Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S009
- Product code
- NPT
- Decision date
- 2022-08-01
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Process changes to ensure retainer alignment to the delivery system handle.
Current openFDA PMA Record#
- Device
- Portico™ Transcatheter Aortic Valve Implantation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S009
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-08-01
- Decision code
- OK30
- Date received
- 2022-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process changes to ensure retainer alignment to the delivery system handle.