|
Trade Name | Codman Enterprise and Enterprise 2 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 | S022 |
Date Received | 06/08/2017 |
Decision Date | 07/05/2017 |
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 Implementation of a new sterilization chamber control system at the sterilization facility to replace the current system. |