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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
carelink device data management application (model 2491) P890003/S247 06/04/2012 Review Approval
carelink enore programmer,carelink 2090 programmer,carelink home monitor,carelink express monitor,cardiosight reader,dev P890003/S297 07/09/2014 Review Approval
carelink home monitor and cardiosight monitor P890003/S209 05/04/2011 Review Approval
carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device P890003/S179 01/09/2012 Review Approval
carelink monitor & cardiosight reader P890003/S169 04/04/2011 Review Approval
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