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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
incepta, energen, punctua and cognis crt-d P010012/S255 11/17/2011 Review Approval
incepta, energen, punctua and teligen icds P960040/S235 11/17/2011 Review Approval
medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators P010031/S178 11/09/2011 Review Approval
medtronic protecta xt dr d314drm, protecta dr d334drm, cardioverter defibrillators P980016/S218 11/09/2011 Review Approval
medtronic carelink monitor model 2490c, cardiosight reader P890003/S181 11/09/2011 Review Approval
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