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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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Review
Memo		 Approval
Order
adapta,versa,sensia,advisa dr,advisa dr mri,enpulse e1,enpulse e2,enrhythm,kappa d(kappa 700),kappa d (kappa 900) ipg, k P980035/S338 09/27/2013 Review Approval
consulta crt-p,syncra crt-p P010015/S208 09/27/2013 Review Approval
fineline ii sterox lead P960004/S060 09/09/2013 Review Approval
carelink programmer model 2090 and model 9790/c programmer P890003/S260 09/05/2013 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S009 08/28/2013 Review Approval
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