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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
PMA NumberP980035
Supplement NumberS309
Date Received02/21/2013
Decision Date03/20/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Ic manufacture test changes for the advisa dr ipg a4dr01, advisa mri ipg a2dr01,consulta crt-p c4tr01, syncra crt-p c2tr01, concerto ii crt-d d274trk, consulta df4 icd d204trm, consulta icd d224trk,maximo ii crt-d d264trm, d284trk, protecta crt-d d334trg, d334trm, protecta xt crt-d d314trg, d314trm, maximo ii icd d264drm, d264vrm, d284drg, d284vrc, protecta icdd334drg, d334drm, d334vrg, d334vrm, protecta xt icd d314drg, d314drm, d314vrg, d314vrm, secura icd d204drm, d204vrm, d224drg, d224vrc, virtuoso ii dr/vr icd d274drg and d274vrc.