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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 ENDOCARDIAL PACING LEADS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameelectrode, pacemaker, permanent and temporary
Regulation Number870.3610
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP960004
Supplement NumberS001
Date Received01/27/1997
Decision Date08/29/1997
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the thinline(tm) ez model 438-10 endocardial pacing lead. This device is indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator.
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