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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.
 
DevicePUNCTUA,TELIGEN,ENERGEN,INCEPTA,VITALITY ICDS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS307
Date Received10/29/2013
Decision Date11/26/2013
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
ADD INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.
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