|
Device | ENDURANT II STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S047 |
Date Received | 04/14/2015 |
Decision Date | 05/06/2015 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR INTRODUCING A LAMP MANDREL AS A MANUFACTURING TOOL FOR THE INSPECTION OF THE RADIOPAQUE CONTRALATERAL GATE MARKER DURING THE MARKER ATTACHMENT PROCESS. |