|
Trade Name | NEUROFORM EZ 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 | S045 |
Date Received | 01/26/2015 |
Decision Date | 02/25/2015 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturing change regarding the device coating. |