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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
Number
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
Decision
Date
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Review
Memo		 Approval
Order
xc202 ceramic capacitor P980035/S153 06/18/2010 Review Approval
quickflex u model 1258t lead P030054/S130 05/10/2010 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
evia / entovis & various other pulse generators P950037/S072 05/07/2010 Review Approval
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t P050023/S024 05/07/2010 Review Approval
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