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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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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
vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) P990001/S105 03/13/2013 Review Approval
concerto, virtuoso (model sw002 v8.0) P980016/S366 03/13/2013 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
kappa 900 (model 9988 v8.0). adapta, versa, sensia (model sw003 v8.0), relia (model sw010 v8.0), enpulse (model 9981 v8. P980035/S280 03/13/2013 Review Approval
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 P030005/S088 03/12/2013 Review Approval
cameron health subcutaneous implantable defibrillator s-icd system P110042/S002 03/07/2013 Review Approval
model 5019 high voltage (hv) splitter/adaptor kit P920015/S093 02/13/2013 Review Approval
linox(smart) s dx steroid-eluting single-coil icd leads P980023/S049 02/13/2013 Review Approval
latitude wave communicator (model 6498) P910077/S119 01/28/2013 Review Approval
reliance 4-site defibrillator lead P910073/S107 12/20/2012 Review Approval
merlin home 6.1m P910023/S307 12/19/2012 Review Approval
merlin net 6.1m P030054/S237 12/19/2012 Review Approval
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers P880086/S202 12/04/2012 Review Approval
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds P910023/S263 12/04/2012 Review Approval
anthem, frontier ii crt-ps P030035/S082 12/04/2012 Review Approval
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
teligen, incepta, energen and punctua icd devices P960040/S270 11/30/2012 Review Approval
cognis, incepta, energen and punctua crt-d devices P010012/S300 11/30/2012 Review Approval
lifevest waerable defibrillator P010030/S031 11/02/2012 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
gem iii at P980050/S076 10/26/2012 Review Approval
entrust,secura,gem ii/iii vr/dr,intrinsic/intrinsic 30,maximo vr/dr,maximo ii,marquis vr/dr,protecta/protecta xt P980016/S376 10/26/2012 Review Approval
stratos lv/lv-t P070008/S031 10/03/2012 Review Approval
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers P950037/S105 10/03/2012 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
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's P050023/S053 10/03/2012 Review Approval
tendril family of leads P960013/S068 09/13/2012 Review Approval
ddma software P890003/S251 09/12/2012 Review Approval
maximo ii df4 icd, secura df4 icd P980016/S362 09/12/2012 Review Approval
icd family of devices & fortify family of devices P910023/S295 08/09/2012 Review Approval
unify quadra crt-d, unify quadra assura P030054/S223 08/09/2012 Review Approval
concert ii, consulta, & maximo ii crt-ds P010031/S296 06/04/2012 Review Approval
maximo ii, secura & virtuoso ii dr/vr icds P980016/S343 06/04/2012 Review Approval
carelink device data management application (model 2491) P890003/S247 06/04/2012 Review Approval
advisa dr ipg P980035/S264 06/04/2012 Review Approval
consulta crt-p, syncra crt-p P010015/S157 06/04/2012 Review Approval
reocor s / d family of external pacemakers P950037/S084 05/08/2012 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S211 05/07/2012 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S089 05/07/2012 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S075 05/07/2012 Review Approval
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds P030054/S206 05/07/2012 Review Approval
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
microny family of pacemakers P970013/S044 05/07/2012 Review Approval
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t P050023/S048 05/04/2012 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
stratos lv/lv-t P070008/S028 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 P000009/S047 05/04/2012 Review Approval
protects xt vr, protecta vr, secura vr maximo ii icd P980016/S280 05/02/2012 Review Approval
medtronic carelink monitor, cardiosight reader P890003/S214 05/02/2012 Review Approval