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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
cameron health subcutaneous implantable defibrillator s-icd system P110042/S002 03/07/2013 Review Approval
capsure sense lead P830061/S086 02/18/2014 Review Approval
capsurefix mri surescan P090013/S202 02/01/2016 Review  
capsurefix novus mri surescan P930039/S140 02/01/2016 Review  
capsurefix novus mri surescan lead model 5076 P930039/S130 06/22/2015 Review  
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