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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
consulta crt-p, syncra crt-p P010015/S190 05/24/2013 Review Approval
intua cardiac resynchronization therapy-pacemaker (crt-p) P030005/S092 05/23/2013 Review Approval
paradym rf crt-d P060027/S038 05/09/2013   Approval
paradym rf vr icds P980049/S071 05/09/2013   Approval
medtronic evera xt dr, evera xt vr, evera s dr, evera s vr implantable cardioverter definrillators P980016/S382 04/03/2013 Review Approval
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