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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.
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
15900 valley view ct.
p.o. box 9221
sylmar, CA 91392-9221
PMA NumberP960013
Supplement NumberS015
Date Received12/08/2005
Decision Date02/07/2006
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the tendril st lead models 1788t/tc and 1782 tc. The devices, as modified, will be marketed under the trade names tendril st model 1788 t, tendril st model 1788tc, and tendril st model 1782tc. The tendril st model 1788 lead is designed for permanent sensing in either the right atrium or the right ventricle, in combination with a compatible pulse generator. The tendril st model 1782 lead is designed for permanent sensing and pacing in the right atrium, in combination with a compatible pulse generator.