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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.
 
DeviceTENDRIL AND OPTISENSE LEAD FAMILIES
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Applicant
PACESETTER, INC.
15900 valley view ct.
p.o. box 9221
sylmar, CA 91392-9221
PMA NumberP960013
Supplement NumberS071
Date Received02/14/2012
Decision Date04/13/2012
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modification to the connector boot on the isoflex tendril st, tendril sts, and optisense lead models, tendril st models 1882, 1888, tendril sts models 1988, 2088 and optisense model 1999.
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