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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 NameST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD
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 NumberS045
Date Received03/19/2009
Decision Date04/16/2009
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for minor labeling changes that enhance instructions for safe device use in the tendril st model 1888 user¿s manual.
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