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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 |
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HDE Number | H050001 |
Supplement Number | S038 |
Date Received | 09/28/2011 |
Decision Date | 03/23/2012 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the hydrophilic coating process methods and software used in the manufacturing of the gateway® pta balloon catheter. |