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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.
DeviceCardiac Resynchronization Therapy- Pacemaker (CRT-P); INVIVE & INTUA MODELS; Ingenio 2 CRT-P Devices VALITUDE MODEL U 12
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ST. PAUL, MN 55112-5798
PMA NumberP030005
Supplement NumberS141
Date Received08/17/2016
Decision Date09/13/2016
Product Code NKE 
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 visual inspection criteria for cosmetic defects.