PMA P190023S003
- Device
- Portico TAVI System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S003
- Product code
- NPT
- Decision date
- 2021-12-13
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval to add a new bovine pericardial tissue supplier.
Current openFDA PMA Record#
- Device
- Portico TAVI System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S003
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-12-13
- Decision code
- APPR
- Date received
- 2021-10-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add a new bovine pericardial tissue supplier.