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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
stratos lv/lv-t P070008/S019 04/15/2011 Review Approval
stratos lv/lv-t P070008/S028 05/04/2012 Review Approval
stratos lv/lv-t P070008/S031 10/03/2012 Review Approval
st jude medical, merlin psa ex3100 system P030054/S146 05/03/2010 Review Approval
sprint quattro secure s mri surescan and sprint quattro secure mri surescan P920015/S151 09/11/2015 Review  
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