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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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Review
Memo		 Approval
Order
dual chamber, implantable pulse generator P820003/S104 05/13/2011 Review Approval
versatrax pacing system P820003/S117 05/30/2013 Review Approval
symbios,synergyst ipgs P820003/S132 10/19/2015 Review Approval
lead tunneler model 6888 P830060/S062 11/10/2010 Review Approval
capsure sense lead P830061/S086 02/18/2014 Review Approval
medtronic carelink programmer P850051/S074 05/13/2011 Review Approval
activitrax ii ipg,activitrax ipg,legend ii ipg,legend ipg,micro minix ipg,minix ipg,minix st ipg,premier ipg,prevail ipg P850051/S082 10/19/2015 Review Approval
senslog/dialog/regency family of pacemakers P880006/S067 03/04/2011 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S070 04/04/2011 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S071 08/03/2011 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S075 05/07/2012 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S081 04/10/2014 Review Approval
integrity afx dr model 5346 dual chamber pulse generator and programmer software model 3307, v2.2a P880086/S083 07/11/2001   Approval
sensolog/dialog/regency family of pacemakers P880006/S084 06/06/2013 Review Approval
sensolog/dialog/ regency family of pacemakers P880006/S087 02/26/2014 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S089 09/12/2014 Review Approval
sensolog / dialog/ regency family of pacemakers P880006/S093 08/27/2015 Review  
affinity/integrity/victory family of pacemakers P880086/S189 03/04/2011 Review Approval
affinity/integrity/victory family of pacemakers P880086/S195 04/04/2011 Review Approval
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers P880086/S202 12/04/2012 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 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/S220 04/10/2014 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/S237 02/26/2014 Review Approval
affinity, integrity, victory, zephyr, & accent family of pacemakers P880086/S245 09/12/2014 Review Approval
affinity/integrity / victory /zephyr accent family of pacemakers P880086/S255 08/27/2015 Review  
carelink monitor & cardiosight reader P890003/S169 04/04/2011 Review Approval
medtronic carelink monitor model 2490c, cardiosight reader P890003/S177 03/25/2011 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/S181 11/09/2011 Review Approval
carelink monitor models 2490g/2491ddma P890003/S189 03/22/2011 Review Approval
carelink ddma software and carelink monitor P890003/S191 10/19/2010 Review Approval
carelink ddma software and carelink monitor P890003/S192 03/22/2011 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 monitor, cardiosight reader P890003/S214 05/02/2012 Review Approval
carelink device data management application (model 2491) P890003/S247 06/04/2012 Review Approval
ddma software P890003/S251 09/12/2012 Review Approval
device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) P890003/S254 03/13/2013 Review Approval
medtronic carelink monitor, cardiosight reader, carelink express P890003/S259 04/03/2013 Review Approval
carelink programmer model 2090 and model 9790/c programmer P890003/S260 09/05/2013 Review Approval
synergyst ii pacing system P890003/S265 05/30/2013 Review Approval
mycarelink patient monitor P890003/S269 05/24/2013 Review Approval
mycarelink patient monitor P890003/S280 09/27/2013 Review Approval
mycarelink patient monitor, device data management application, application software P890003/S285 02/14/2014 Review Approval
mycarelink monitor, P890003/S295 02/27/2014 Review Approval
carelink enore programmer,carelink 2090 programmer,carelink home monitor,carelink express monitor,cardiosight reader,dev P890003/S297 07/09/2014 Review Approval
carelink monitor,cardiosight reader,carelink express,device data management application(ddma) P890003/S309 07/03/2014 Review Approval
elite,elite ii,minuet,preva,prodigy,thera d,thera dr ipgs, thera id pg,thera ipg,thera s ipg,thera sr ipg,thera vdd ipg, P890003/S326 10/19/2015 Review Approval
 
 
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