|
Device | Portico™ Transcatheter Heart Valve |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P190023 |
Supplement Number | S004 |
Date Received | 11/08/2021 |
Decision Date | 12/16/2021 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Discontinuation of passive monitoring procedures in ISO Class 7 and 8 cleanrooms. |