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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 PERMANENT PACING LEAD MODELS
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960030
Supplement NumberS010
Date Received02/11/2003
Decision Date04/10/2003
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for reduced lead body size for the passive plus dx lead. The device, as modified, will be marketed under the trade name isoflex s and is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (models 1643k and 1642t) or ventricle (models 1645k and 1646t).
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