|
Trade Name | GASTRIC ELECTRICAL STIMULATION (GES) SYSTEM |
Classification Name | intestinal stimulator |
Generic Name | intestinal stimulator |
Applicant |
Enterra Medical, Inc. |
5353 wayzata blvd. |
suite 400 |
st. louis park, MN 55416 |
|
HDE Number | H990014 |
Supplement Number | S113 |
Date Received | 03/04/2016 |
Decision Date | 03/31/2016 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Assembly of hybrid assemblies manufactured at medtronic tempe campus using the assembleon pick and place machine. |