|
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 | S085 |
Date Received | 07/17/2018 |
Decision Date | 08/15/2018 |
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/control system, upgrades to the vacuum pump system, and introduction of parametric release for several ethylene oxide (eo) sterilization chambers at the boston scientific corporation (bsc) coventry, rhode island facility for the gateway pta balloon catheter. |