|
Device | TRIVASCULAR, INC. OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 3910 Brickway Blvd Santa Rosa, CA 95403 |
PMA Number | P120006 |
Supplement Number | S004 |
Date Received | 06/27/2013 |
Decision Date | 08/27/2013 |
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 OF THE POST-APPROVAL STUDY PROTOCOL. |