|
Trade Name | 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 | S090 |
Date Received | 03/15/2019 |
Decision Date | 04/12/2019 |
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 Modification of the inspection and shelf life evaluation for neopentyl glycol diacrylate (npgda), which is a component within the hydrophilic coatings of the gateway pta balloon catheter. |