|
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 | S212 |
Date Received | 05/03/2022 |
Decision Date | 05/12/2022 |
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 Approval for changes to the "final acceptance procedures for hybrid modules and assemblies" and the "hybrid final pack and bag rfid process specifications" procedures to correct identified gaps in standard work as determined during a capa investigation. |