|
Trade Name | ENTERRA/ ENTERRA II THERAPY SYSTEMS |
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 | S108 |
Date Received | 09/16/2015 |
Decision Date | 10/16/2015 |
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 removal of the external parylene coating from the enterra ii implantable neurostimulator model 37800. The device, as modified, will be marketed under the trade name enterra ii therapy system and is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. |