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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
corox otw-l bp left ventricular pacing lead P070008/S015 12/23/2010 Review Approval
cylos/dr/dr-t/vr/dromos dr/sr/sl/kairos dr/sr/sl/d/s/philos/dr/dr-t/sr/slr/d/s/philos ii d/dr/s/slr/sr/dr-t/protos dr/cl P950037/S100 05/04/2012 Review Approval
ddma software P890003/S251 09/12/2012 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
dema ipg/c & t series ipgs P990001/S082 05/13/2011 Review Approval
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