|
Trade Name | Neuroform 3 Microdelivery Stent System |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Stryker Neurovascular |
47900 bayside parkway |
fremont, CA 94538 |
|
HDE Number | H020002 |
Supplement Number | S047 |
Date Received | 01/27/2016 |
Decision Date | 02/26/2016 |
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 To replace the material for the luer component of the purchased pre-assembled hoop assembly for the neuro renegade hi-flo delivery catheter from pro-fax pd 626 to bormed hd810mo polypropylene resin. The neuro renegade hi-flo packaging hoop will serve as the packaging hoop for the neuroform 3 microdelivery stent system. |