|
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 | S104 |
Date Received | 06/17/2015 |
Decision Date | 07/16/2015 |
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 expand the upper limit of the temperature range for the conditioning phase of the standard sterilization cycle at the medtronic neuromodulation sullivan lake and rice creek manufacturing facilities. |