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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
attain ability mri , plus mri,straight mri surescan; attain performa mri, straight ans s mri surescan P080006/S085 02/01/2016 Review  
sprint quattro secure s mri surescan ; sprint quattro secure mri surescan P920015/S163 02/01/2016 Review  
capsurefix novus mri surescan P930039/S140 02/01/2016 Review  
capsurefix mri surescan P090013/S202 02/01/2016 Review  
carelink monitor, cardiosight reader, carelink express monitor P890003/S338 02/01/2016 Review  
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