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. |
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Trade Name | GASTRIC ELECTRICAL STIMULATION (GES) SYSTEM |
Classification Name | intestinal stimulator |
Generic Name | intestinal stimulator |
Applicant |
Enterra Medical, Inc. |
5353 wayzata blvd. |
suite 400 |
st. louis park, MN 55416 |
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HDE Number | H990014 |
Supplement Number | S112 |
Date Received | 02/08/2016 |
Decision Date | 04/21/2016 |
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 changes made to the model 8840 n'vision® clinician programmer including replacement of pcba components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, physician manual labeling changes, emc declaration changes, device labeling changes and packaging labeling changes. |
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