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

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | 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 PMA to get an up-to-date view of this device.
 
Trade NameITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable programmable neurological electrical pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS067
Date Received03/24/2003
Decision Date05/09/2003
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the snap lid screening cable, the octad percutaneous extension and the octad stylet which are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.
-
-