|
Trade Name | ENTERRA INS/UNIPOLAR MUSCULAR LEAD |
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 | S065 |
Date Received | 08/04/2011 |
Decision Date | 09/21/2011 |
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 to modify the model 4351 leads for two proposed changes:1) change from platinized (i. E. , platinum sputtered) mp35n conductor coil to non-platinized (i. E. , bare or non-platinum sputtered mp35n conductor coil); and2) change from standard titanium mp35n conductor coil material to low titanium mp35n conductor coil material. |