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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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Review
Memo		 Approval
Order
5086 mri capsurefix mri surescan leads P090013/S200 09/11/2015 Review  
revo mri ipg P090013/S165 10/19/2015 Review Approval
revo mri ipg P090013/S112 02/14/2014 Review Approval
revo mri ipg P090013/S107 09/27/2013 Review Approval
revo mri ipg P090013/S085 05/24/2013 Review Approval
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