Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | AMPLATZER SEPTAL AND CRIBRIFORM OCCLUDERS |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P000039 |
Supplement Number | S046 |
Date Received | 05/14/2012 |
Decision Date | 06/06/2012 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement USE OF DIFFERENT BRAIDING EQUIPMENT TO REDUCE THE POTENTIAL FOR ABRASION OF NITINOL WIRE. |
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