|
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 |
|
HDE Number | H050001 |
Supplement Number | S084 |
Date Received | 12/01/2017 |
Decision Date | 12/27/2017 |
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 Integrate the new total automated coiling system (tcs) into the coating, packaging, and self expanding stents (cps) area; integrate new z-axis vacuum decay testing (vdt) testers into the tcs; and integrate new z-axis vdt testing into the existing semi-automated coiling process. |