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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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Review
Memo
Approval
Order
dual chamber, implantable pulse generator P820003/S104 05/13/2011 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
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
dema ipg/c & t series ipgs P990001/S082 05/13/2011 Review Approval
ddma software P890003/S251 09/12/2012 Review Approval
cylos/dr/dr-t/vr/dromos dr/sr/sl/kairos dr/sr/sl/d/s/philos/dr/dr-t/sr/slr/d/s/philos ii d/dr/s/slr/sr/dr-t/protos dr/cl P950037/S100 05/04/2012 Review Approval
corox otw-l bp left ventricular pacing lead P070008/S015 12/23/2010 Review Approval
corox otw-l bp leads P070008/S026 09/30/2011 Review Approval
consulta crt-p,syncra crt-p P010015/S208 09/27/2013 Review Approval
consulta crt-p, syncra crt-p P010015/S190 05/24/2013 Review Approval
consulta crt-p, syncra crt-p P010015/S157 06/04/2012 Review Approval
consulta crt-p, advisa (model 9995 v8.0) consulta crt-d, secura (model 9995 v8.0) insync iii, maximo ii, concerto ii P010031/S319 03/13/2013 Review Approval
consulta crt-d/concerto ii crt-d/maximo crt-d icds P010031/S150 04/04/2011 Review Approval
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization P010015/S084 03/22/2011 Review Approval
concerto, virtuoso (model sw002 v8.0) P980016/S366 03/13/2013 Review Approval
concerto ii/maximo ii/consulta crt-ds P010031/S228 05/13/2011 Review Approval
concerto ii/consulta/maximo ii crt-ds P010031/S198 03/22/2011 Review Approval
concerto ii/consulta/insync ii marquis/iii marquis/insync maximo/sentry/maximo ii/protecta/protecta xt P010031/S252 08/18/2011 Review Approval
concerta, consulta/consulta df4, & various insync families of icd's; concerto ii, maximo ii,protecta,protecta xt crt-d's P010031/S329 10/26/2012 Review Approval
concert ii, consulta, & maximo ii crt-ds P010031/S296 06/04/2012 Review Approval
cognis, incepta, energen and punctua crt-d devices P010012/S300 11/30/2012 Review Approval
cognis 4-site models P010012/S212 11/10/2010 Review Approval
cellpaker plasma collection device P050044/S019 01/31/2012 Review Approval
carelink programmer model 2090 and model 9790/c programmer P890003/S260 09/05/2013 Review Approval
carelink monitor models 2490g/2491ddma P890003/S189 03/22/2011 Review Approval
carelink monitor & cardiosight reader P890003/S169 04/04/2011 Review Approval
carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device P890003/S179 01/09/2012 Review Approval
carelink home monitor and cardiosight monitor P890003/S209 05/04/2011 Review Approval
carelink device data management application (model 2491) P890003/S247 06/04/2012 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
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 P030005/S088 03/12/2013 Review Approval
cardiac resynchronization therapy defibrillator (crt-d) P030054/S173 11/29/2011 Review Approval
capsure sense lead P830061/S086 02/18/2014 Review Approval
cameron health subcutaneous implantable defibrillator s-icd system P110042/S002 03/07/2013 Review Approval
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
cadence/current/fortify families of icds P910023/S257 06/21/2011 Review Approval
cadence family of icds P910023/S270 03/09/2012 Review Approval
cadence family of icds P910023/S215 01/29/2010 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 family of icds P910023/S264 08/03/2011 Review Approval
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds P000009/S040 11/26/2010 Review Approval
belos dr/dr-t/vr/vr-t/lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t/xelos dr-t P000009/S047 05/04/2012 Review Approval
belos dr/dr-t/vr/vr-t, lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's P000009/S049 10/03/2012 Review Approval
belos & lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's P000009/S051 03/18/2013 Review Approval
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds P910023/S263 12/04/2012 Review Approval
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
anthem, frontier ii crt-ps P030035/S082 12/04/2012 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 Review Approval
 
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