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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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PMA
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Review
Memo		 Approval
Order
insync crt-p/insync iii crt-p P010015/S107 05/13/2011 Review Approval
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar P900061/S098 05/13/2011 Review Approval
carelink home monitor and cardiosight monitor P890003/S209 05/04/2011 Review Approval
reliaty / model 3145 family of pacing system analyzers P950037/S088 04/20/2011 Review Approval
lifevest wearable defibrillator P010030/S023 04/19/2011 Review Approval
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