|
Trade Name | ENTERRA/ ENTERRA II THERAPY SYSTEMS |
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 | S106 |
Date Received | 07/23/2015 |
Decision Date | 08/20/2015 |
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 final functional testing (fft) software of the implantable neurostimulators at medtronic puerto rico operations in juncos, puerto rico. |