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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
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
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.