|
Device | RelayPlus Thoracic Stent-Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | BOLTON MEDICAL, INC. 799 INTERNATIONAL PARKWAY SUNRISE, FL 33325 |
PMA Number | P110038 |
Supplement Number | S016 |
Date Received | 11/17/2017 |
Decision Date | 12/08/2017 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the Instructions for Use including clarifications regarding device deployment directions, as well as other minor administrative and editorial changes. |