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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, cardiosight reader, carelink express P890003/S259 04/03/2013 Review Approval
carelink programmer model 2090 and model 9790/c programmer P890003/S260 09/05/2013 Review Approval
synergyst ii pacing system P890003/S265 05/30/2013 Review Approval
mycarelink patient monitor P890003/S269 05/24/2013 Review Approval
mycarelink patient monitor P890003/S280 09/27/2013 Review Approval
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