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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
Classification Namepermanent pacemaker electrode
Generic Nameimplantable endocardial pacemaker lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960004
Supplement NumberS014
Date Received05/26/2000
Decision Date11/21/2000
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the silicone and polyurethane thinline(tm) ii sterox and fineline(tm) ii steroid eluting pacing leads. The devices are indicated for chronic pacing and sensing of the ventricle and/or atrium when used with a compatible pulse generator.
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