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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
medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators P980016/S211 03/25/2011 Review Approval
medtronic carelink monitor model 2490c, cardiosight reader P890003/S177 03/25/2011 Review Approval
evia / entovis family of pulse generators P950037/S091 03/25/2011 Review Approval
medtronic selectsecure lead model 3830 P030036/S004 03/30/2011 Review Approval
medtronic attain ability straight model 4396 left ventricular lead P080006/S004 03/31/2011 Review Approval
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