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 | 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 |
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HDE Number | H990014 |
Supplement Number | S178 |
Date Received | 11/15/2019 |
Decision Date | 12/11/2019 |
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 Update medtronics manufacturing software, manufacturing execution system to factory works (release 9. 7), which is comprised of (1) fw business rule client 9. 7, (2) fw configuration client 9. 2. 2, and (3) integrated manufacturing process management (impm) web services (ws) 3. 6. |
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