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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 LEAD FAMILY
Classification Namepermanent defibrillator electrodes
Generic Namealternate endocardial lead stabilizer component
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP950001
Supplement NumberS022
Date Received04/01/2011
Decision Date04/29/2011
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 No
Approval Order Statement 
Change in biological indicator model used as part of the manufacturing process.
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