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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 MODELS 2088TC & 1988TC LEADS
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 NumberS060
Date Received05/13/2010
Decision Date06/10/2010
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Alternate vendor for the soft tip component.
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