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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
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds P000009/S046 09/30/2011 Review Approval
corox otw-l bp leads P070008/S026 09/30/2011 Review Approval
transcyte human fibroblast-derived temporary skin substitute P960007/S021 09/20/2011 Review Approval
concerto ii/consulta/insync ii marquis/iii marquis/insync maximo/sentry/maximo ii/protecta/protecta xt P010031/S252 08/18/2011 Review Approval
entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii P980016/S298 08/18/2011 Review Approval
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