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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
medtronics carelink home monitor and cardiosight reader P890003/S211 05/13/2011 Review Approval
concerto ii/maximo ii/consulta crt-ds P010031/S228 05/13/2011 Review Approval
legend plus family of pacemakers P930022/S012 05/13/2011 Review Approval
medtronic carelink programmer P850051/S074 05/13/2011 Review Approval
kappa 400 dr/sr ipgs P970012/S081 05/13/2011 Review Approval
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