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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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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
stratos lv/lv-t P070008/S031 10/03/2012 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
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
gem iii at P980050/S076 10/26/2012 Review Approval
lifevest waerable defibrillator P010030/S031 11/02/2012 Review Approval
cognis, incepta, energen and punctua crt-d devices P010012/S300 11/30/2012 Review Approval
teligen, incepta, energen and punctua icd devices P960040/S270 11/30/2012 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
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
merlin home 6.1m P910023/S307 12/19/2012 Review Approval
merlin net 6.1m P030054/S237 12/19/2012 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
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
cameron health subcutaneous implantable defibrillator s-icd system P110042/S002 03/07/2013 Review Approval
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 P030005/S088 03/12/2013 Review Approval
insync iii (model 9981 v8.0) P010015/S166 03/13/2013 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
device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) P890003/S254 03/13/2013 Review Approval
concerto, virtuoso (model sw002 v8.0) P980016/S366 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
vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) P990001/S105 03/13/2013 Review Approval
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's P070008/S036 03/18/2013 Review Approval
various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. P950037/S116 03/18/2013 Review Approval
ilesto 7/ 5 vr-t icd, iforia 7/ 5 vr-t icd, ilesto 7/ 5 vr-t dx icd, ilforia 7/ 5 vr-t dx icd, ilesto 7/ 5 dr-t icd P050023/S058 03/18/2013 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
medtronic carelink monitor, cardiosight reader, carelink express P890003/S259 04/03/2013 Review Approval
medtronic evera xt dr, evera xt vr, evera s dr, evera s vr implantable cardioverter definrillators P980016/S382 04/03/2013 Review Approval
intua cardiac resynchronization therapy-pacemaker (crt-p) P030005/S092 05/23/2013 Review Approval
consulta crt-p, syncra crt-p P010015/S190 05/24/2013 Review Approval
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd P010031/S363 05/24/2013 Review Approval
revo mri ipg P090013/S085 05/24/2013 Review Approval
mycarelink patient monitor P890003/S269 05/24/2013 Review Approval
entrust icd, intrinsic 30 icd, intrinsic icd, intrinsic icd, marquis dr icd, marquis vr icd, maximo dr icd, maximo vr ic P980016/S400 05/24/2013 Review Approval
adapta versa, sensia ipg, advisa dr ipg, advisa dr mri ipg and enpulse e1 ipg P980035/S311 05/24/2013 Review Approval
versatrax pacing system P820003/S117 05/30/2013 Review Approval
synergyst ii pacing system P890003/S265 05/30/2013 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S107 06/06/2013 Review Approval
quadra assura/unify assura family of crt-ds P030054/S238 06/06/2013 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S084 06/06/2013 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S229 06/06/2013 Review Approval
ellipse/fortify assura family of icds P910023/S309 06/06/2013 Review Approval
microny family pacemakers P970013/S054 06/06/2013 Review Approval
spectranetics laser sheath P960042/S043 06/14/2013 Review Approval
reply/esprit sr and dr model pacemakers P950029/S079 06/20/2013 Review Approval