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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 attain ability plus model 4296 lead P080006/S002 04/01/2011 Review Approval
microny family of pacemakers P970013/S038 04/04/2011 Review Approval
consulta crt-d/concerto ii crt-d/maximo crt-d icds P010031/S150 04/04/2011 Review Approval
frontier/frontier ii family of crt-ps P030035/S075 04/04/2011 Review Approval
advisa dr ipg P980035/S134 04/04/2011 Review Approval
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