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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 | S075 |
Date Received | 12/07/2015 |
Decision Date | 01/06/2016 |
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 eliminate balloon profile sample inspections performed at the beginning of the manufacturing process of the gateway pta balloon catheter at boston scientific's maple grove, mn facility where the gateway pta balloon catheter is manufactured. |