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 | TALENT ABDOMINAL STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P070027 |
Supplement Number | S019 |
Date Received | 06/04/2010 |
Decision Date | 07/01/2010 |
Withdrawal Date
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03/06/2017 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING. |
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