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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 NameTENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Namecardiovascular permanent pacemaker electrode
Regulation Number870.3680
ApplicantPACESETTER, INC.
PMA NumberP960013
Supplement NumberS001
Date Received09/24/1997
Decision Date03/19/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of thermedics tecothane t11075d-m for molded polyurethane components as a replacement for pellethane 2363-75d. Fda also acknowledges your marketing of the tenril dx model 1388t/c lead, which is identical to the approved model 1388t lead, except that it is packaged only with the clip-on tool accessory.
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