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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.
 
DeviceLEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 6931
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910073
Supplement NumberS046
Date Received06/14/2004
Decision Date07/06/2004
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE SUPPLIER FOR THE MOLD RELEASE, A CHANGE IN THE TYPE OF LUBRICANT, AND A CHANGE IN THE PROCESS OF APPLYING THE LUBRICANT.
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