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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.
 
DeviceTELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS284
Date Received12/26/2012
Decision Date01/22/2013
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES TO THE SPUTTERED CERAMIC LAPPING PROCESS USED DURING FEEDTHRU ASSEMBLY.
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