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 NameMEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS091
Date Received01/20/2006
Decision Date02/08/2006
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised text to the caution in the "placing a percutaneous lead" section of the instructions for use section of the following manuals: model 3898 pisces-octad lead kit implant manual, model 3487 a pisces quad, model 3887 pisces quad compact, and model 3888 pisces quad plus lead kits implant manual, and model 3890 pisces z quad, model 3891 pisces z quad compact, and model 3892 pisces z quad plus lead kits implant manual.
-
-