• 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 | Inspections
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 NameRESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS195
Date Received07/29/2011
Decision Date08/26/2011
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the manual for the model 8840 nvision clinician programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (emi) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other medtronic labeling for external programming devices.
-
-