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 NameENTERRA INTESTINAL STIMULATOR
Classification Nameintestinal stimulator
Generic Nameintestinal stimulator
Applicant
Enterra Medical, Inc.
5353 wayzata blvd., suite 400
st. louis park, MN 55416
HDE NumberH990014
Supplement NumberS069
Date Received03/29/2012
Decision Date05/21/2012
Product Code
LNQ[ Registered Establishments with LNQ ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for revised labeling, which includes the following: 1) the addition of caution statements related to the potential uncomfortable stimulation, which somepatients have described as a jolting, shocking or burning sensation; 2) a discussion of the parameter settings that were used in medtronic-sponsored clinical studies,including stimulus intensity, pulse width, and pulse frequency. The enterra therapy guide also contains a table of the maximum voltage that should be applied without inducing tissue damage, given a range of lead impedances; and 3) caution statements to take care when increasing the stimulation parameters for therapy titration toavoid adverse effects and uncomfortable stimulation effects when the stimulation parameters are increased.
-
-