The FDA’s Center for Devices & Radiological Health released a selection of summary review memos detailing applications to make substantial changes to already-approved medical devices.
The federal watchdog agency’s med-tech oversight arm said it began releasing the documents as part of the CDRH’s transparency initiative. The 180-day supplements seek to make "a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report," according to the agency.
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Premarket approval (PMA) summary review memos for 180-day design changes
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds | P000009/S046A> | 09/30/2011 | Review | Approval |
lumax 300/340 vr-t/dr-t/hf-t/lumax 500/540 vr-t/dr-t/hf-t/lumax 540 vr-t dx | P050023/S046 | 09/30/2011 | Review | Approval |
corox otw-l bp leads | P070008/S026 | 09/30/2011 | Review | Approval |
evia/entovis/estella/effecta/ecuro | P950037/S098 | 09/30/2011 | Review | Approval |
transcyte human fibroblast-derived temporary skin substitute | P960007/S021 | 09/20/2011 | 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 |
entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii | P980016/S298 | 08/18/2011 | Review | Approval |
frontier/frontierii/anthem family of crt-ps | P030035/S083 | 08/03/2011 | Review | Approval |
epic hf/atlas + hf family of crt-ds | P030054/S189 | 08/03/2011 | Review | Approval |
sensolog/dialog/regency family of pacemakers | P880006/S071 | 08/03/2011 | Review | Approval |
affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S203 | 08/03/2011 | Review | Approval |
cadence family of icds | P910023/S264 | 08/03/2011 | Review | Approval |
microny family of pacemakers | P970013/S040 | 08/03/2011 | Review | Approval |
restylane injectable gel | P040024/S052 | 07/18/2011 | Review | Approval |
cadence/current/fortify families of icds | P910023/S257 | 06/21/2011 | Review | Approval |
epic hf/atlas+hf/promote/unify families of crt-ds | P030054/S181 | 06/21/2011 | Review | Approval |
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin | P990004/S019 | 05/17/2011 | Review | Approval |
insync crt-p/insync iii crt-p | P010015/S107 | 05/13/2011 | Review | Approval |
concerto ii/maximo ii/consulta crt-ds | P010031/S228 | 05/13/2011 | Review | Approval |
dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
medtronic carelink programmer | P850051/S074 | 05/13/2011 | Review | Approval |
medtronics carelink home monitor and cardiosight reader | P890003/S211 | 05/13/2011 | Review | Approval |
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar | P900061/S098 | 05/13/2011 | Review | Approval |
legend plus family of pacemakers | P930022/S012 | 05/13/2011 | Review | Approval |
kappa 400 dr/sr ipgs | P970012/S081 | 05/13/2011 | Review | Approval |
virtuoso ii/secura/maximo ii icds | P980016/S273 | 05/13/2011 | Review | Approval |
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs | P980035/S200 | 05/13/2011 | Review | Approval |
transvene cs/svc lead | P980050/S057 | 05/13/2011 | Review | Approval |
dema ipg/c & t series ipgs | P990001/S082 | 05/13/2011 | Review | Approval |
carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
lifevest wearable defibrillator | P010030/S023 | 04/19/2011 | Review | Approval |
implantable cv defibrillator/pacemaker programmer/icd monitoring system | P000009/S042 | 04/15/2011 | 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/S039 | 04/15/2011 | Review | Approval |
stratos lv/lv-t | P070008/S019 | 04/15/2011 | Review | Approval |
implantable pacemaker pulse generator,pacemaker programming | P950037/S089 | 04/15/2011 | Review | Approval |
sensolog/dialog/regency family of pacemakers | P880006/S070 | 04/04/2011 | Review | Approval |
affinity/integrity/victory family of pacemakers | P880086/S195 | 04/04/2011 | Review | Approval |
carelink monitor & cardiosight reader | P890003/S169 | 04/04/2011 | Review | Approval |
cadence family of icds | P910023/S254 | 04/04/2011 | Review | Approval |
microny family of pacemakers | P970013/S038 | 04/04/2011 | Review | Approval |
secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds | P980016/S187 | 04/04/2011 | Review | Approval |
advisa dr ipg | P980035/S134 | 04/04/2011 | Review | Approval |
consulta crt-d/concerto ii crt-d/maximo crt-d icds | P010031/S150 | 04/04/2011 | Review | Approval |
frontier/frontier ii family of crt-ps | P030035/S075 | 04/04/2011 | Review | Approval |
epic hf/atlas+hf hamily of crt-ds | P030054/S177 | 04/04/2011 | Review | Approval |
medtronic attain ability plus model 4296 lead | P080006/S002 | 04/01/2011 | Review | Approval |
medtronic attain ability straight model 4396 left ventricular lead | P080006/S004 | 03/31/2011 | Review | Approval |
medtronic selectsecure lead model 3830 | P030036/S004 | 03/30/2011 | Review | Approval |
protecta xt crt-d and protecta crt-d implantable cardioverter defibrillators with cardiac resynchronization; model sw009 | P010031/S171 | 03/25/2011 | Review | Approval |
medtronic carelink monitor model 2490c, cardiosight reader | P890003/S177 | 03/25/2011 | Review | Approval |
evia / entovis family of pulse generators | P950037/S091 | 03/25/2011 | Review | Approval |
medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators | P980016/S211 | 03/25/2011 | Review | Approval |
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization | P010015/S084 | 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 |
carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
carelink ddma software and carelink monitor | P890003/S192 | 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 |
dema ipg/c & t series ipgs | P990001/S068 | 03/22/2011 | Review | Approval |
microny family of pacemakers | P970013/S034 | 03/04/2011 | Review | Approval |
frontier/frontier 2 family of crt-ps | P030035/S070 | 03/04/2011 | Review | Approval |
epic hr/atlas + hf family of crt-ds | P030054/S153 | 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 |
durata family of leads | P950022/S069 | 01/24/2011 | Review | Approval |
corox otw-l bp left ventricular pacing lead | P070008/S015 | 12/23/2010 | Review | Approval |
medtronics adapta, versa, sensia and relia implantable pulse generator | P980035/S150 | 12/08/2010 | 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 |
evia/entovis dr/dr-t/sr-t & various other models of pulse generators | P950037/S083 | 11/26/2010 | Review | Approval |
optisense model 1999 lead | P960013/S057 | 11/26/2010 | Review | Approval |
cognis 4-site models | P010012/S212 | 11/10/2010 | Review | Approval |
lead tunneler model 6888 | P830060/S062 | 11/10/2010 | Review | Approval |
endotak reliance 4-site leads and accessories | P910073/S077 | 11/10/2010 | Review | Approval |
teligen 4-site models | P960040/S198 | 11/10/2010 | Review | Approval |
carelink ddma software and carelink monitor | P890003/S191 | 10/19/2010 | Review | Approval |
enrythm ipg | P980016/S237 | 10/19/2010 | Review | Approval |
entrust icd family | P980035/S166 | 10/19/2010 | Review | Approval |
linox smart steroid-eluting dual-coil icd leads | P980023/S038 | 09/17/2010 | 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 |
reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | Review | Approval |
xc202 ceramic capacitor | P980035/S153 | 06/18/2010 | Review | Approval |
quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
evia/entovis pulse generators | P000009/S035 | 05/07/2010 | Review | Approval |
unify crt-d system | P030054/S141 | 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 |
evia / entovis & various other pulse generators | P950037/S072 | 05/07/2010 | Review | Approval |
st jude medical, merlin psa ex3100 system | P030054/S146 | 05/03/2010 | Review | Approval |
tendril sts lead model 1988tc | P960013/S054 | 04/14/2010 | Review | Approval |
paradym crt-d model 8750 | P060027/S015 | 04/07/2010 | Review | Approval |
paradym vr model 8250 & dr model 8550 | P980049/S050 | 04/07/2010 | Review | Approval |
epic hf crt-d system | P030054/S131 | 01/29/2010 | Review | Approval |
restylane l and perlane l injectable gels | P040024/S039 | 01/29/2010 | Review | Approval |
cadence family of icds | P910023/S215 | 01/29/2010 | Review | Approval |
juvederm ultra xc and juvederm ultra plus xc | P050047/S005 | 01/07/2010 | Review | Approval |
floseal hemostatic matrix 5 ml/10 ml kit | P990009/S025 | 01/07/2010 | Review | Approval |
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