PMA P190023S004
- Device
- Portico™ Transcatheter Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S004
- Product code
- NPT
- Decision date
- 2021-12-16
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Discontinuation of passive monitoring procedures in ISO Class 7 and 8 cleanrooms.
Current openFDA PMA Record#
- Device
- Portico™ Transcatheter Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P190023
- Supplement
- S004
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-12-16
- Decision code
- OK30
- Date received
- 2021-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Discontinuation of passive monitoring procedures in ISO Class 7 and 8 cleanrooms.