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Trade Name | GATEWAY 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 | S078 |
Date Received | 05/04/2016 |
Decision Date | 06/01/2016 |
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 Subcontractor and supplier of their sterile barrier pouch, to move their pouch material coating operations from one processing location to another. The subcontractor currently produces the finished pouch at the final location and all processing will now be done at a single location. |