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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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Decision
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Review
Memo		 Approval
Order
cadence family of icds P910023/S270 03/09/2012 Review Approval
cadence family of icds P910023/S254 04/04/2011 Review Approval
cadence/current/fortify families of icds P910023/S257 06/21/2011 Review Approval
cadence/ellipse/fortify assura family of icd's P910023/S297 04/10/2014 Review Approval
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
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