|
Trade Name | Wingspan Stent System with Gateway PTA Balloon Catheter |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
STRYKER CORP. |
47900 bayside parkway |
fremont, CA 94538 |
|
HDE Number | H050001 |
Supplement Number | S101 |
Date Received | 08/30/2023 |
Decision Date | 02/12/2024 |
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 Approval for a material change to the proximal outer tube of the gateway pta balloon catheter and a change to the particulate test method and specification of the gateway pta balloon catheter. |