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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 PICOTIP BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/SELUTE BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/ATRAIL J SELUTE
Classification Namepermanent defibrillator electrodes
Generic Namealternate endocardial lead stabilizer component
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP950001
Supplement NumberS020
Date Received12/16/2009
Decision Date01/12/2010
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in the biological indicator used for the sterilization process.
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