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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
medtronic carelink monitor, cardiosight reader, carelink express P890003/S259 04/03/2013 Review Approval
ilesto 7/ 5 vr-t icd, iforia 7/ 5 vr-t icd, ilesto 7/ 5 vr-t dx icd, ilforia 7/ 5 vr-t dx icd, ilesto 7/ 5 dr-t icd P050023/S058 03/18/2013 Review Approval
various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. P950037/S116 03/18/2013 Review Approval
belos & lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's P000009/S051 03/18/2013 Review Approval
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's P070008/S036 03/18/2013 Review Approval
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