|
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 | S052 |
Date Received | 08/13/2018 |
Decision Date | 01/11/2019 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03055858
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the AMPLATZER Piccolo Occluder. |
Post-Approval Study | Show Report Schedule and Study Progress |