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 NameSOLETRA/KINETRA/EXTERNAL/ACTIVA FAMILY OF NEUROSTIMULATORS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS100
Date Received10/26/2010
Decision Date11/24/2010
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system.
-
-