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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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Review
Memo		 Approval
Order
xelos dr-t icd's P000009/S057 05/04/2014 Review Approval
xc202 ceramic capacitor P980035/S153 06/18/2010 Review Approval
volta(1cr/2cr/ct/2ct) icd lead, protego (s/sd/t/td) icd lead,kainox vcs 60 icd leadlinox smart (s/sd/t/td/s dx) icd lead P980023/S060 09/16/2014 Review Approval
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
viva crt-p,consulta crt-p,syncra crt-p P010015/S227 07/09/2014 Review Approval
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