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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(TM)II/FINELINE(TM) II LEADS
Classification Namepermanent pacemaker electrode
Generic Nameimplantable endocardial pacemaker lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960004
Supplement NumberS013
Date Received05/15/2000
Decision Date06/09/2000
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing facility located at guidant puerto rico b. V. , dorado, puerto rico, 00646 and the sterilization facility located at guidant corporation, st. Paul, minnesota, 55112.
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