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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
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Decision
Date
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Review
Memo
Approval
Order
intensia crt-d P060027/S066 11/04/2014   Approval
instensia icd P980049/S099 11/04/2014   Approval
volta(1cr/2cr/ct/2ct) icd lead, protego (s/sd/t/td) icd lead,kainox vcs 60 icd leadlinox smart (s/sd/t/td/s dx) icd lead P980023/S060 09/16/2014 Review Approval
dextrus, selox st/jt, setrox s, and tilda t/jt/r steroid-eluting pacing leads; solox slx -bp pacing lead P950037/S138 09/16/2014 Review Approval
celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead P070008/S054 09/16/2014 Review Approval
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