Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
|
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 | S126 |
Date Received | 11/03/2016 |
Decision Date | 11/28/2016 |
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 Changes to the integrated circuit wafer manufacturing process flow for the 1. 5µm high-density (hd) bipolar and complementary metal oxide semiconductor (bicmos) at the singapore amk6 fabrication facility of medtronics supplier, stmicroelectronics. |
|
|