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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
corox otw-l bp left ventricular pacing lead P070008/S015 12/23/2010 Review Approval
evia/entovis pulse generators P070008/S011 05/07/2010 Review Approval
intensia crt-d P060027/S066 11/04/2014   Approval
attain starfix lead P060039/S059 09/04/2014 Review Approval
paradym rf:models vr 9250, dr 9550, crt-d 9750; paradym models vr 8250, dr 8550, crt-d 8750 P060027/S053 03/06/2014 Review Approval
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