|
Device | AMPLATZER DUCT OCCLUDER |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P020024 |
Supplement Number | S023 |
Date Received | 02/11/2009 |
Decision Date | 04/08/2009 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATION IN PACKAGING MATERIALS AND THE USE OF A NEW SEALER TO ACCOMMODATE THE NEW PACKAGING MATERIALS. |
Post-Approval Study | Show Report Schedule and Study Progress |