PMA P190023S008
- Device
- Portico Transcatheter Aortic Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S008
- Product code
- NPT
- Decision date
- 2022-07-07
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Addition of a new abattoir to source bovine pericardium and a change to the in-process tissue shelf life.
Current openFDA PMA Record#
- Device
- Portico Transcatheter Aortic Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S008
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-07-07
- Decision code
- OK30
- Date received
- 2022-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new abattoir to source bovine pericardium and a change to the in-process tissue shelf life.