Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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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 | S083 |
Date Received | 11/13/2017 |
Decision Date | 12/12/2017 |
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 To sterilize the gateway pta balloon catheter with the optimized bsc2000-2 ethylene oxide cycle in chambers 1, 2, 3, 5, 6, 7, 8, 9 and 10 at bsc coventry, rhode island. |
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