|
Device | AMPLATZER DUCT OCCLUDER II |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P020024 |
Supplement Number | S040 |
Date Received | 09/11/2013 |
Decision Date | 11/08/2013 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |