|
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 | S034 |
Date Received | 04/25/2013 |
Decision Date | 12/26/2013 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at stryker neurovascular (snv), fremont-b4, 47900 bayside parkway, fremont, california 94538. |