|
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 |
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HDE Number | H990014 |
Supplement Number | S014 |
Date Received | 10/06/2005 |
Decision Date | 02/21/2006 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in your quality inspection process f-or the titanium can seamn weld analysis. |