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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 STS 1988TC AND 2088TC
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 NumberS066
Date Received07/22/2011
Decision Date11/01/2011
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for three additional lead lengths of 65, 85 and 100 cm in the tendril sts pacemaker leads.
Approval Order Approval Order
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