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Trade Name | Gastro-Electrical Stimulation (GES) Neurostimulators Implantable Enterra Family |
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 | S224 |
Date Received | 06/06/2023 |
Decision Date | 06/29/2023 |
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 To update the resistance spot welding (rsw) process for medium rate batteries. |