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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
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Decision
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Review
Memo
Approval
Order
lifevest wearable defibrillator P010030/S023 04/19/2011 Review Approval
reliaty / model 3145 family of pacing system analyzers P950037/S088 04/20/2011 Review Approval
carelink home monitor and cardiosight monitor P890003/S209 05/04/2011 Review Approval
medtronics carelink home monitor and cardiosight reader P890003/S211 05/13/2011 Review Approval
medtronic carelink programmer P850051/S074 05/13/2011 Review Approval
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