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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.
 
DeviceINVIVE,INTUA CRT-PS
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant
GUIDANT CORP.
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP030005
Supplement NumberS104
Date Received10/29/2013
Decision Date11/26/2013
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
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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