|
Trade Name | CODMAN ENTERPRISE & ENTERPRISE 2 Vascular Reconstruction Devices 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 | S023 |
Date Received | 12/26/2018 |
Decision Date | 01/25/2019 |
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 Transfer the pre-sterilization quality control activities for the codman enterprise® and enterprise® vascular reconstruction devices and delivery systems from the codman raynham, ma site to other approved sites and to remove a redundant quality test (pre-sterilization one-piece inspection) from the receiving inspection (ri) procedure (codman raynham, ma). |