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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceINVIVE,INTUA CRT-PS
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS104
Date Received10/29/2013
Decision Date11/26/2013
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
  We welcome your comments and feedback about Devices@FDA.
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