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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NameISOFLEX OPTIM LEADS
Classification Namepermanent defibrillator electrodes
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960030
Supplement NumberS020
Date Received01/17/2008
Decision Date03/18/2008
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for device modifications to the isoflex optim family of leads. The devices, as modified, will be marketed under the trade names isoflex optim model 1944t and isoflex optim 1948t.
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