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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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PMA
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Review
Memo		 Approval
Order
belos dr/dr-t/vr/vr-t/lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t/xelos dr-t P000009/S047 05/04/2012 Review Approval
stratos lv/lv-t P070008/S028 05/04/2012 Review Approval
protects xt vr, protecta vr, secura vr maximo ii icd P980016/S280 05/02/2012 Review Approval
medtronic carelink monitor, cardiosight reader P890003/S214 05/02/2012 Review Approval
invive v172, v173 P030005/S079 05/01/2012 Review Approval
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