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.
 
DeviceOPTISURE
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP950022
Supplement NumberS085
Date Received10/24/2012
Decision Date02/21/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE OPTISURE HIGH VOLTAGE LEAD FAMILY.
Post-Approval StudyShow Report Schedule and Study Progress