|
Trade Name | Enterra II Programmable Neurostimulator for Gastric Electrical Stimulation |
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 | S159 |
Date Received | 10/01/2018 |
Decision Date | 10/22/2018 |
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 Manufacturing change to substrate material of the stacked chip scale package. |