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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
sensolog / dialog/ regency family of pacemakers P880006/S093 08/27/2015 Review  
cardiomems hf pressure measurement system P100045/S002 07/10/2015 Review  
capsurefix novus mri surescan lead model 5076 P930039/S130 06/22/2015 Review  
advisa sr ipg P980035/S424 06/22/2015 Review  
attain performa model 4398 and 4598 left ventricular leads P080006/S073 12/10/2014 Review  
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