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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.
 
DeviceFLEXTEND LEADS
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP960006
Supplement NumberS032
Date Received01/24/2012
Decision Date02/29/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the bacterial endotoxin sampling plan.
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