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 | THE TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P070027 |
Supplement Number | S017 |
Date Received | 05/03/2010 |
Decision Date | 06/18/2010 |
Withdrawal Date
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03/06/2017 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC IRELAND, GALWAY, IRELAND, FOR FINAL ASSEMBLY PROCESSES AND FOR ISOTRON IRELAND, LTD., TULLAMORE, IRELAND, FOR STERILIZATION SERVICES. |
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