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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
medtronics carelink home monitor and cardiosight reader P890003/S211 05/13/2011 Review Approval
medtronic carelink monitor, cardiosight reader P890003/S214 05/02/2012 Review Approval
carelink device data management application (model 2491) P890003/S247 06/04/2012 Review Approval
ddma software P890003/S251 09/12/2012 Review Approval
device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) P890003/S254 03/13/2013 Review Approval
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