|
Trade Name | MEDTRONIC ENTERRA LEAD MODEL 4351 |
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 | S013 |
Date Received | 06/30/2005 |
Decision Date | 07/08/2005 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a precaution in the model 8840 n'vision programmer technical manual regarding the potential risk of using the device in aflammable environment. |