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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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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
evera s dr icd,evera s vr icd, evera xt dr icd,evera xt vr icd, viva/brava/evera programmer application software P980016/S451 02/27/2014 Review Approval
ellipse/fortify assura family of icds P910023/S323 02/26/2014 Review Approval
quadra assura/unify assura family pf crt-ds P030054/S254 02/26/2014 Review Approval
sensolog/dialog/ regency family of pacemakers P880006/S087 02/26/2014 Review Approval
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