|
Trade Name | NEUROFORM MICRODELIVERY STENT |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Stryker Neurovascular |
47900 bayside parkway |
fremont, CA 94538 |
|
HDE Number | H020002 |
Supplement Number | S002 |
Date Received | 02/10/2003 |
Decision Date | 02/28/2003 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modfications to markerbands: (1) chamfering the edges to reduce the deployment force of the stent and (2) changing the material to 90% platinum with 10% iridium to address the potential cracking of the markerbands during crimping onto the stent loops. |