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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 NameTHINLINE II/FINELINE II STEROX PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Namecardiovascular permanent pacemaker electrode
Regulation Number870.3680
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP960004
Supplement NumberS017
Date Received12/26/2000
Decision Date02/15/2001
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at guidant puerto rico, dorado, puerto rico. The manufacturing site will perform the sterilization, packaging and labeling of the device.
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