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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
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Decision
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Review
Memo
Approval
Order
5076 capsurefix novus surescan leads P930039/S138 09/11/2015 Review  
5086 mri capsurefix mri surescan leads P090013/S200 09/11/2015 Review  
evera mri xt dr, xt vr, s dr, s vr surescan icd's P980016/S536 09/11/2015 Review  
sprint quattro secure s mri surescan and sprint quattro secure mri surescan P920015/S151 09/11/2015 Review  
carelink monitor and express monitor, cardiosight reader; carelink express P890003/S329 09/11/2015 Review  
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