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 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 | S010 |
Date Received | 11/14/2005 |
Decision Date | 04/25/2007 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
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 A NEW DELIVERY SYSTEM AND MODIFICATIONS TO THE DEVICE PACKAGING. THE DEVICES, WITH THE MODIFIED DELIVERY SYSTEMS, WILL BE MARKETED UNDER THE TRADE NAME TORQVUE DELIVERY AND EXCHANGE SYSTEMS. |
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