|
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 | S079 |
Date Received | 05/27/2016 |
Decision Date | 06/20/2016 |
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 Updates to your programmable logic controller (plc) software and the vacuum pump activation settings used in sterilization chamber 8 at your boston scientific (bsc) coventry rhode island site for sterilization of your gateway pta balloon catheter. |