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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.
 
Trade NameMAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC, INC.
PMA NumberP980016
Supplement NumberS399
Date Received02/21/2013
Decision Date03/20/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
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 icd d334drg, d334drm, d334vrg, d334vrm, protecta xt icd d314drg, d314drm, d314vrg, d314vrm, secura icd d204drm, d204vrm, d224drg, d224vrc, virtuoso ii dr/vr icd d274drg and d274vrc.
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