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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
sensolog/ dialog/regency family of pacemakers P880006/S089 09/12/2014 Review Approval
attain starfix lead P060039/S059 09/04/2014 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S029 08/22/2014 Review Approval
viva crt-p,consulta crt-p,syncra crt-p P010015/S227 07/09/2014 Review Approval
carelink enore programmer,carelink 2090 programmer,carelink home monitor,carelink express monitor,cardiosight reader,dev P890003/S297 07/09/2014 Review Approval
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