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Device | VALIANT THORACIC STENT GRAFT WITH CAPTIVA 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 | S025 |
Date Received | 08/31/2015 |
Decision Date | 04/22/2016 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for 1) a site change for inspection and packaging/shipping of delivery system components; 2) addition of a visual inspection process; and 3) change in a detergent for machining operations. |