|
Trade Name | CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Medos International, SARL |
chemin-blanc 38 |
le locle 2400 |
|
HDE Number | H060001 |
Supplement Number | S010 |
Date Received | 06/28/2010 |
Decision Date | 08/16/2010 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to revise an existing statement in the precaution section and move it to the warning section of the labeling. |