|
Device | TRIVASCULAR, INC OVATION/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 | S017 |
Date Received | 10/21/2014 |
Decision Date | 01/14/2015 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01092117
|
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE CUSTOMSEAL KIT. |
Post-Approval Study | Show Report Schedule and Study Progress |