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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 AND THINLINE II/FINELINE II STEROX LEADS
Classification Namepermanent pacemaker electrode
Generic Nameactive fixation transvenous bipolar pacing lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960004
Supplement NumberS019
Date Received10/04/2001
Decision Date10/26/2001
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to create separate accessory packs which will include the models 6220 and 6221 suture sleeves.
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