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

510(k) Premarket Notification
  • 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
Device Classification Name stimulator, spinal-cord, implanted (pain relief)
510(K) Number K113611
Model 3834
Device Name RAPID PROGRAMMER
Applicant
ST. JUDE MEDICAL
6901 preston road
plano,  TX  75024
Contact teri gilio
Regulation Number882.5880
Classification Product Code
GZB  
Date Received12/21/2011
Decision Date 04/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-