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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 P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Namecardiovascular permanent pacemaker electrode
Regulation Number870.3680
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960030
Supplement NumberS012
Date Received08/03/2004
Decision Date04/27/2005
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of a polyurethane insulator. The devices, as modified, will be marketed under the trade names isoflex p 1644t and isoflex p 1648t leads and are indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (model 1644t) or ventricle (model 1648t).
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