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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 Nameactive fixation transvenous bipolar pacing lead
Regulation Number870.3680
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP960004
Supplement NumberS018
Date Received02/20/2001
Decision Date04/06/2001
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of mannitol as an alternate material to cover the helix on the above referenced active fixation pacing leads. The devices are indicated for permanent pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
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