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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
Name
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PMA
Number
Sort by PMA Number [0-9]
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Decision
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Review
Memo		 Approval
Order
programmer software(1503.u) for ics 3000/renamic programmers P000009/S063 12/21/2015 Review  
programmer software (1503.u) for the ics 3000/renamic programmers P070008/S063 12/21/2015 Review  
paradym vr/dr P980049/S065 04/10/2012   Approval
paradym vr model 8250 & dr model 8550 P980049/S050 04/07/2010 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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