|
Device | ENDURANT AND ENDURANT II 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 | S038 |
Date Received | 06/09/2014 |
Decision Date | 07/08/2014 |
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 RADIOPAQUE CONTRALATERAL GATE MARKER INSPECTION OF ENDURANT AND ENDURANT II BIFURCATED STENT GRAFTS AND A COIL DISPENSER AS A VISUAL AID DURING THE PRE-KITTING PROCESS OF ENDURANT II STENT GRAFTS. |