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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
Name
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PMA
Number
Sort by PMA Number [0-9]
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Review
Memo		 Approval
Order
sprint quattro secure s mri surescan and sprint quattro secure mri surescan P920015/S151 09/11/2015 Review  
sprint quattro secure s mri surescan ; sprint quattro secure mri surescan P920015/S163 02/01/2016 Review  
legend plus family of pacemakers P930022/S012 05/13/2011 Review Approval
legend plus ipg P930022/S017 10/19/2015 Review Approval
capsurefix novus mri surescan lead model 5076 P930039/S130 06/22/2015 Review  
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