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 | VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100040 |
Supplement Number | S022 |
Date Received | 05/26/2015 |
Decision Date | 06/25/2015 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MANUFACTURING THE VALIANT 17 APEX SINGLE TAA SUPPORT SPRING AT THE MEDTRONIC MEXICO EG MANUFACTURING SITE. |
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