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U.S. Department of Health and Human Services

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

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As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Links to all available summary review memos can be found here.

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Device
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viva quad xt crt-d,viva quad s crt-d,brava quad crt-d,viva quad c crt-d,viva/brava/evera software application P010031/S442 07/03/2014 Review Approval
carelink monitor,cardiosight reader,carelink express,device data management application(ddma) P890003/S309 07/03/2014 Review Approval
latitude nxt 2.0 patient management system P910077/S140 06/20/2014 Review Approval
attain ability model 4x96 lead P080006/S063 05/15/2014 Review Approval
entovis promri pacemaker system P950037/S132 05/04/2014 Review Approval
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