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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
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Review
Memo		 Approval
Order
carelink monitor and express monitor, cardiosight reader; carelink express P890003/S329 09/11/2015 Review  
carelink monitor, cardiosight reader, carelink express monitor P890003/S338 02/01/2016 Review  
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar P900061/S098 05/13/2011 Review Approval
medtronic gem icd,medtronic jewel icd,medtronic jewel plus icd,medtronic micro jewel icd,medtronic micro jewel ii icd,me P900061/S133 10/19/2015 Review Approval
endotak reliance 4-site leads and accessories P910073/S077 11/10/2010 Review Approval
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