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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 model 2490c, cardiosight reader P890003/S181 11/09/2011 Review Approval
carelink monitor models 2490g/2491ddma P890003/S189 03/22/2011 Review Approval
carelink ddma software and carelink monitor P890003/S191 10/19/2010 Review Approval
carelink ddma software and carelink monitor P890003/S192 03/22/2011 Review Approval
carelink home monitor and cardiosight monitor P890003/S209 05/04/2011 Review Approval
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