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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
attain ability mri , plus mri,straight mri surescan; attain performa mri, straight ans s mri surescan P080006/S085 02/01/2016 Review  
attain performa model 4398 and 4598 left ventricular leads P080006/S073 12/10/2014 Review  
attain ability model 4x96 lead P080006/S063 05/15/2014 Review Approval
medtronic attain ability straight model 4396 left ventricular lead P080006/S004 03/31/2011 Review Approval
medtronic attain ability plus model 4296 lead P080006/S002 04/01/2011 Review Approval
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