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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 Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
15900 valley view ct.
p.o. box 9221
sylmar, CA 91392-9221
PMA NumberP960013
Supplement NumberS025
Date Received11/30/2006
Decision Date05/07/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the optisense model 1699t and 1699tc leads. The device, as modified, will be marketed under the trade name optisense model 1699t and 1699tc leads and are designed for permanent sensing and pacing in the right atrium, in combination with a compatible pulse generator. An active fixation lead such as the model 1699 may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.