|
Trade Name | Enterra Therapy 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 | S163 |
Date Received | 12/26/2018 |
Decision Date | 03/08/2019 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in material purity of niobium wire stock; second-tier raw material supplier change for niobium wire stock; lubricant change for wire drawing process; and process change to anneal wire prior to wire drawing process. |