|
Trade Name | Neuroform Atlas, EZ, and 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 | S053 |
Date Received | 09/20/2018 |
Decision Date | 10/05/2018 |
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 Reduction of the frequency of in-process inspection for the pouch sealing process to once daily. |