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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 NamePASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
ApplicantPACESETTER, INC.
PMA NumberP960030
Supplement NumberS005
Date Received04/01/1999
Decision Date08/26/1999
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 1336t passive plus(r) dx endocardial, steroid eluting, passive fixation pacing lead. This device is indicated for permanent pacing and sensing of the ventricle when used with a compatible pulse generator.
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