• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVNS THERAPY SYSTEM
Classification Namestimulator, autonomic nerve, implanted (depression)
Generic Namestimulator, autonomic nerve, implanted (depression)
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP970003
Supplement NumberS166
Date Received11/01/2013
Decision Date05/09/2014
Product Code
MUZ[ Registered Establishments with MUZ ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELING THAT DESCRIBES THE CONDITIONS UNDER WHICH MAGNETIC RESONANCE IMAGING (MRI) CAN BE USED WHEN RESIDUAL VNS LEADS OR LEAD FRAGMENTS (ABANDONED LEADS) REMAIN IN THE BODY.
-
-