|
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 | S091 |
Date Received | 03/21/2019 |
Decision Date | 04/19/2019 |
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 Updates to the programmable logic controller (plc) software and upgrades to the vacuum pump system for bsc coventry sterilization chamber 7. |