Humanitarian Device Exemption (HDE)

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 Name: ENTERRA INTESTINAL STIMULATOR
• 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: S069
• Date Received: 03/29/2012
• Decision Date: 05/21/2012
• Product Code: LNQ [ Registered Establishments with LNQ ]
• Advisory Committee: Gastroenterology
• Supplement Type: normal 75 day track
• Supplement Reason: labeling change - indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

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.