|
Trade Name | NEUROFORM2 AND NEUROFORM3 MICRODELIVERY STENT SYSTEMS |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Stryker Neurovascular |
47900 bayside parkway |
fremont, CA 94538 |
|
HDE Number | H020002 |
Supplement Number | S013 |
Date Received | 04/23/2008 |
Decision Date | 05/14/2008 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revising the product instructions for use to include the alternative stent transfer method. |