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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFLEXTEND FAMILY OF LEADS
Generic NamePermanent defibrillator electrodes
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960006
Supplement NumberS019
Date Received11/09/2005
Decision Date12/08/2005
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
ADDITION OF A SECOND SUPPLIER FOR THE FLUORO RING COMPONENT USED FOR IDENTIFYING THE POSITION OF THE ELECTRODE DURING FLUOROSCOPY.
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