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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 NameTENDRIL STS LEAD MODEL 2088TC
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960013
Supplement NumberS046
Date Received03/31/2009
Decision Date05/26/2009
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for distal tip changes to the tendril st model 1888 lead family. The device, as modified, will be marketed under the trade name tendril sts model 2088tc, and are transvenous steroid eluting leads indicated for use in the right atrium or right ventricle, in combination with a compatible pulse generator.
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