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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
Name
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PMA
Number
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Decision
Date
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Review
Memo
Approval
Order
medtronic attain ability plus model 4296 lead P080006/S002 04/01/2011 Review Approval
advisa dr ipg P980035/S134 04/04/2011 Review Approval
carelink monitor & cardiosight reader P890003/S169 04/04/2011 Review Approval
consulta crt-d/concerto ii crt-d/maximo crt-d icds P010031/S150 04/04/2011 Review Approval
secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds P980016/S187 04/04/2011 Review Approval
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