|
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 | S009 |
Date Received | 01/06/2015 |
Decision Date | 03/06/2015 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO INCREASE THE RATE OF ENROLLMENT TO A MORE ACCEPTABLE RATE IN THE POST-APPROVAL STUDY PROTOCOL. |