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Device | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | BOLTON MEDICAL, INC. 799 INTERNATIONAL PARKWAY SUNRISE, FL 33325 |
PMA Number | P110038 |
Supplement Number | S012 |
Date Received | 06/21/2016 |
Decision Date | 09/19/2016 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate material and joining method for the delivery system secondary sheath (also referred to as the constraining sleeve). |