|
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 | S082 |
Date Received | 08/21/2017 |
Decision Date | 09/15/2017 |
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 A manufacturing change to remove the in-process burst testing for the outer shaft of gateway pta balloon catheter. This change does not involve the wingspan® stent system and also does not impact the burst testing performed on the distal balloon portion of the gateway pta catheter. |