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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
programmer software (1503.u) for the ics 3000/renamic programmers P070008/S063 12/21/2015 Review  
linox smart s65,linox smart sd 65/18,linox s dx 65/15,linox s dx 65/17,protego df-1 s 65,protego df-1 sd 65/18,protego d P980023/S072 12/21/2015 Review  
origen, inogen, and dynagen icd, incepta, energen, and punctua icd, teligen icd P960040/S360 12/21/2015 Review  
origen, inogen, and dynagen crt-d, incepta energen punctua crt-d, cognis crt-d P010012/S405 12/21/2015 Review  
evera s dr icd, evera s vr icd, evera xt dr icd, evera xt vr icd P980016/S548 10/29/2015 Review  
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