|
Device | INCRAFT(R) AAA STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Cordis US Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P150002 |
Supplement Number | S008 |
Date Received | 03/31/2020 |
Decision Date | 09/23/2020 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01664078
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updating the labeling to include 5-year INSPIRATION study data and minor editorial changes. |