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 ENDOLUMINALOCCLUDER SYSTEM |
Generic Name | system, endovascular graft, aortic aneurysm treatment |
Applicant |
Medtronic Vascular |
3576 unocal place |
santa rosa, CA 95403 |
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PMA Number | P070027 |
Supplement Number | S031 |
Date Received | 08/12/2011 |
Decision Date | 09/07/2011 |
Product Code |
MIH
|
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
CHANGE TO THE FIRM¿S STERILIZATION PROCESS. |
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