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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
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization P010015/S084 03/22/2011 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
insync crt-p & insync iii crt-p P010015/S086 03/22/2011 Review Approval
carelink ddma software and carelink monitor P890003/S192 03/22/2011 Review Approval
kappa 400 dr/sr ipg P970012/S068 03/22/2011 Review Approval
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