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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 NameSELUTE(R) PICOTIP(TM) STEROID-ELUTING ENDOCARDIAL ATRIAL-J LEADS
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous bipolar pacing lead
ApplicantGUIDANT CORP.
PMA NumberP950001
Supplement NumberS004
Date Received11/15/1999
Decision Date05/10/2000
Product Code
NVY[ Registered Establishments with NVY ]
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 atrial j selute picotip steroid eluting pacing lead, models 4063 and 4064.
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