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 NameDEEP BRAIN STIMULATION FOR OBSESSIVE-COMPULSIVE DISORDER
Classification Namestimulator, brain, implanted, for behavior modification
Generic Namestimulator, brain, implanted, for behavior modification
Applicant
MEDTRONIC INC.,NEUROLOGICAL DIVISION
7000 central avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS003
Date Received01/07/2010
Decision Date03/24/2010
Product Code
MFR[ Registered Establishments with MFR ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the reformulation of the hotmelt adhesive used for medtronic neuromodulation sterile barrier blister packages.
-
-