PMA P190023S011

Device
Portico™
Applicant
ABBOTT MEDICAL
PMA number
P190023
Supplement
S011
Product code
NPT
Decision date
2022-12-14
Generic name
Aortic valve, prosthesis, percutaneously delivered
Approval order statement
Modification to the test method used to verify sterilant, storage, and fixation solution concentrations.

Current openFDA PMA Record#

Device
Portico™
Applicant
ABBOTT MEDICAL
PMA number
P190023
Supplement
S011
Product code
NPT
Generic name
Aortic valve, prosthesis, percutaneously delivered
Decision date
2022-12-14
Decision code
OK30
Date received
2022-11-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the test method used to verify sterilant, storage, and fixation solution concentrations.