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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 | S014 |
Date Received | 09/16/2016 |
Decision Date | 10/13/2016 |
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 |
Approval Order Statement Use of an automatic drilling machine in the manufacture of the rotator body component of the Relay Thoracic Stent-Graft Plus Delivery System. |