|
Device | TRI VASCULAR, INC. OVATION /OVATION 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 | S016 |
Date Received | 10/29/2014 |
Decision Date | 11/20/2014 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01092117
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement MODIFIED AND NEW TOOLS FOR USE IN THE PROCESS FOR LOADING THE STENT GRAFTS INTOTHE DELIVERY SYSTEM SHEATHS. |
Post-Approval Study | Show Report Schedule and Study Progress |