|
Device | Amplatzer Piccolo™ Occluder |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P020024 |
Supplement Number | S067 |
Date Received | 11/04/2022 |
Decision Date | 03/27/2023 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the Instructions for Use to include the 3-year follow up data on patients enrolled in the ADO II AS Clinical Study (IDE and Continued Access Cohorts). |