PMA P190023S006

Device: Portico Transcatheter Aortic Heart Valve
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S006
Product code: NPT
Decision date: 2022-03-04
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Change to the final device label stock and implementation of a new printer to aid in the production of the final packaging labels for the Portico Valve.

Current openFDA PMA Record#

Device: Portico Transcatheter Aortic Heart Valve
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S006
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2022-03-04
Decision code: OK30
Date received: 2022-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the final device label stock and implementation of a new printer to aid in the production of the final packaging labels for the Portico Valve.