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Trade Name | WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLON 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 | S064 |
Date Received | 04/17/2014 |
Decision Date | 11/07/2014 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a nickel titanium (nitinol)allergy warning to the labeling, and to update the magnetic resonance (mr) sections of the labeling to add the mr conditional status of the device. |