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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 PACING LEADS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable endocardial pacemaker lead
Regulation Number870.3610
ApplicantGUIDANT CORP.
PMA NumberP960004
Supplement NumberS012
Date Received05/15/2000
Decision Date06/07/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Five minor changes made to the thinline ii(tm) and fineline ii(tm) manufacturing processes.
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