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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 protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators P980016/S211 03/25/2011 Review Approval
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization P010015/S084 03/22/2011 Review Approval
carelink ddma software and carelink monitor P890003/S192 03/22/2011 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/senia ipgs P980035/S168 03/22/2011 Review Approval
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