|
Trade Name | NEUROFORM MICRODELIVERY STENT SYSTEM |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Stryker Neurovascular |
47900 bayside parkway |
fremont, CA 94538 |
|
HDE Number | H020002 |
Supplement Number | S030 |
Date Received | 11/14/2011 |
Decision Date | 06/21/2012 |
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 |