|
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 | S062 |
Date Received | 04/15/2020 |
Decision Date | 07/09/2020 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT04371081
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the Amplatzer Piccolo occluder Instructions for Use (IFU). |