|
Device | AMPLATZER SEPTAL OCCLUDER |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P000039 |
Supplement Number | S002 |
Date Received | 03/12/2002 |
Decision Date | 05/03/2002 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A CAUTION LABEL. |