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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
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
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/S084 06/06/2013 Review Approval
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/S229 06/06/2013 Review Approval
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
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar P900061/S098 05/13/2011 Review Approval
endotak reliance 4-site leads and accessories P910073/S077 11/10/2010 Review Approval
endotak reliance is-i passive fixation P910073/S091 01/05/2012 Review Approval
reliance 4-site defibrillator lead P910073/S107 12/20/2012 Review Approval
latitude wave communicator (model 6498) P910077/S119 01/28/2013 Review Approval
cadence family of icds P910023/S215 01/29/2010 Review Approval
fortify dr / vr icd systems P910023/S226 05/07/2010 Review Approval
cadence family of icds P910023/S236 03/04/2011 Review Approval
cadence family of icds P910023/S254 04/04/2011 Review Approval
cadence/current/fortify families of icds P910023/S257 06/21/2011 Review Approval
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds P910023/S263 12/04/2012 Review Approval
cadence family of icds P910023/S264 08/03/2011 Review Approval
cadence family of icds P910023/S270 03/09/2012 Review Approval
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
icd family of devices & fortify family of devices P910023/S295 08/09/2012 Review Approval
merlin home 6.1m P910023/S307 12/19/2012 Review Approval
 
 
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