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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
Date
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Review
Memo
Approval
Order
carelink device data management application (model 2491) P890003/S247 06/04/2012 Review Approval
medtronic carelink monitor, cardiosight reader P890003/S214 05/02/2012 Review Approval
medtronics carelink home monitor and cardiosight reader P890003/S211 05/13/2011 Review Approval
carelink home monitor and cardiosight monitor P890003/S209 05/04/2011 Review Approval
carelink ddma software and carelink monitor P890003/S192 03/22/2011 Review Approval
carelink ddma software and carelink monitor P890003/S191 10/19/2010 Review Approval
carelink monitor models 2490g/2491ddma P890003/S189 03/22/2011 Review Approval
medtronic carelink monitor model 2490c, cardiosight reader P890003/S181 11/09/2011 Review Approval
carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device P890003/S179 01/09/2012 Review Approval
medtronic carelink monitor model 2490c, cardiosight reader P890003/S177 03/25/2011 Review Approval
carelink monitor & cardiosight reader P890003/S169 04/04/2011 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S229 06/06/2013 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S220 04/10/2014 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S211 05/07/2012 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 Review Approval
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers P880086/S202 12/04/2012 Review Approval
affinity/integrity/victory family of pacemakers P880086/S195 04/04/2011 Review Approval
affinity/integrity/victory family of pacemakers P880086/S189 03/04/2011 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S084 06/06/2013 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S081 04/10/2014 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S075 05/07/2012 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S071 08/03/2011 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S070 04/04/2011 Review Approval
senslog/dialog/regency family of pacemakers P880006/S067 03/04/2011 Review Approval
medtronic carelink programmer P850051/S074 05/13/2011 Review Approval
capsure sense lead P830061/S086 02/18/2014 Review Approval
lead tunneler model 6888 P830060/S062 11/10/2010 Review Approval
versatrax pacing system P820003/S117 05/30/2013 Review Approval
dual chamber, implantable pulse generator P820003/S104 05/13/2011 Review Approval
 
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