Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameMEDTRONIC ENTERRA LEAD MODEL 4351
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd.
suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS009
Date Received03/07/2003
Decision Date04/10/2003
Product Code
LNQ[ Registered Establishments with LNQ ]
Docket Number OOM-1415
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to include a modified stimulation desktop software (referred to as the mgu stimulation desktop application) which limits use of the model 8870 application card to only the intcrstlm and en terra'" applications. Other changes requested include the removal of the model 8529 magnet used with the synchromed drug pump application from the programmmg unit, and the modification of the labelmg to reflect these changes.
-
-