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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.
 
DeviceLOCATOR STEERABLE STYLET MODEL 4036
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
Applicant
PACESETTER, INC.
15900 valley view ct.
p.o. box 9221
sylmar, CA 91392-9221
PMA NumberP960013
Supplement NumberS002
Date Received12/12/1997
Decision Date06/15/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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