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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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floseal hemostatic matrix 5 ml/10 ml kit P990009/S025 01/07/2010 Review Approval
juvederm ultra xc and juvederm ultra plus xc P050047/S005 01/07/2010 Review Approval
restylane l and perlane l injectable gels P040024/S039 01/29/2010 Review Approval
epic hf crt-d system P030054/S131 01/29/2010 Review Approval
cadence family of icds P910023/S215 01/29/2010 Review Approval
paradym vr model 8250 & dr model 8550 P980049/S050 04/07/2010 Review Approval
paradym crt-d model 8750 P060027/S015 04/07/2010 Review Approval
tendril sts lead model 1988tc P960013/S054 04/14/2010 Review Approval
st jude medical, merlin psa ex3100 system P030054/S146 05/03/2010 Review Approval
evia / entovis & various other pulse generators P950037/S072 05/07/2010 Review Approval
evia/entovis pulse generators P000009/S035 05/07/2010 Review Approval
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t P050023/S024 05/07/2010 Review Approval
evia/entovis pulse generators P070008/S011 05/07/2010 Review Approval
fortify dr / vr icd systems P910023/S226 05/07/2010 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
quickflex u model 1258t lead P030054/S130 05/10/2010 Review Approval
xc202 ceramic capacitor P980035/S153 06/18/2010 Review Approval
reliaty/model 3145 pacing system analyzer P950037/S079 09/02/2010 Review Approval
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P060027/S026 09/09/2010 Review Approval
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P980049/S059 09/09/2010 Review Approval
linox smart steroid-eluting dual-coil icd leads P980023/S038 09/17/2010 Review Approval
enrythm ipg P980016/S237 10/19/2010 Review Approval
entrust icd family P980035/S166 10/19/2010 Review Approval
carelink ddma software and carelink monitor P890003/S191 10/19/2010 Review Approval
teligen 4-site models P960040/S198 11/10/2010 Review Approval
cognis 4-site models P010012/S212 11/10/2010 Review Approval
endotak reliance 4-site leads and accessories P910073/S077 11/10/2010 Review Approval
lead tunneler model 6888 P830060/S062 11/10/2010 Review Approval
optisense model 1999 lead P960013/S057 11/26/2010 Review Approval
evia/entovis dr/dr-t/sr-t & various other models of pulse generators P950037/S083 11/26/2010 Review Approval
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds P000009/S040 11/26/2010 Review Approval
various models of lumax icd/crt-d families P050023/S033 11/26/2010 Review Approval
stratos lv/lv-t crt-p P070008/S017 11/26/2010 Review Approval
medtronics adapta, versa, sensia and relia implantable pulse generator P980035/S150 12/08/2010 Review Approval
corox otw-l bp left ventricular pacing lead P070008/S015 12/23/2010 Review Approval
durata family of leads P950022/S069 01/24/2011 Review Approval
epic hr/atlas + hf family of crt-ds P030054/S153 03/04/2011 Review Approval
frontier/frontier 2 family of crt-ps P030035/S070 03/04/2011 Review Approval
senslog/dialog/regency family of pacemakers P880006/S067 03/04/2011 Review Approval
affinity/integrity/victory family of pacemakers P880086/S189 03/04/2011 Review Approval
cadence family of icds P910023/S236 03/04/2011 Review Approval
microny family of pacemakers P970013/S034 03/04/2011 Review Approval
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization P010015/S084 03/22/2011 Review Approval
carelink monitor models 2490g/2491ddma P890003/S189 03/22/2011 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
kappa 400 dr/sr ipg P970012/S068 03/22/2011 Review Approval
secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds P980016/S240 03/22/2011 Review Approval
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/senia ipgs P980035/S168 03/22/2011 Review Approval
insync crt-p & insync iii crt-p P010015/S086 03/22/2011 Review Approval
concerto ii/consulta/maximo ii crt-ds P010031/S198 03/22/2011 Review Approval