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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 S LEAD MODEL 1646T
Classification Namepermanent defibrillator electrodes
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960030
Supplement NumberS013
Date Received09/09/2005
Decision Date10/17/2005
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 an alternate manufacturing process and material for the isoflex s 1646t lead.
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