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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
Name
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PMA
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Decision
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Review
Memo
Approval
Order
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software P010031/S413 02/27/2014 Review Approval
brava,brava quad,concerto ii,consulta,maximo ii,protecta,protecta xt,viva quad s, viva quad xt,viva s, viva xt crt-ds, c P010031/S478 10/19/2015 Review Approval
cadence family of icds P910023/S236 03/04/2011 Review Approval
cadence family of icds P910023/S215 01/29/2010 Review Approval
cadence family of icds P910023/S264 08/03/2011 Review Approval
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