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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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Review
Memo
Approval
Order
versatrax pacing system P820003/S117 05/30/2013 Review Approval
various models of lumax icd/crt-d families P050023/S033 11/26/2010 Review Approval
various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. P950037/S116 03/18/2013 Review Approval
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers P950037/S105 10/03/2012 Review Approval
unify quadra crt-d, unify quadra assura P030054/S223 08/09/2012 Review Approval
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