|
Trade Name | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Medos International, SARL |
chemin-blanc 38 |
le locle 2400 |
|
HDE Number | H060001 |
Supplement Number | S019 |
Date Received | 01/28/2016 |
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 Moving the assembly location of the delivery wire of the enterprise vascular reconstruction device and delivery system from 340 lake hazeltine drive, chaska, mn to 304 lake hazeltine drive, chaska, mn. |