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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
maximo ii df4 icd, secura df4 icd P980016/S362 09/12/2012 Review Approval
ddma software P890003/S251 09/12/2012 Review Approval
protecta df4 icd, protecta icd, protecta xt df4 icd, protecta xt icd P980016/S361 09/10/2012 Review  
protecta crt-d, protecta df4 crt-d, protecta xt crt-d, protecta xt df4 crt-d P010031/S314 09/10/2012 Review  
icd family of devices & fortify family of devices P910023/S295 08/09/2012 Review Approval
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