|
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 | S117 |
Date Received | 06/09/2016 |
Decision Date | 07/07/2016 |
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 Addition of new peel test and pouch seal equipment used in the pouch sealing process and blister package and pouch peel testing process and introduction of a new peel test operation procedure at the medtronic sullivan lake facility. |