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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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Review
Memo		 Approval
Order
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
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
cognis, incepta, energen and punctua crt-d devices P010012/S300 11/30/2012 Review Approval
concert ii, consulta, & maximo ii crt-ds P010031/S296 06/04/2012 Review Approval
incepta, energen, punctua and cognis crt-d P010012/S255 11/17/2011 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
concerto ii/maximo ii/consulta crt-ds P010031/S228 05/13/2011 Review Approval
cognis 4-site models P010012/S212 11/10/2010 Review Approval
concerto ii/consulta/maximo ii crt-ds P010031/S198 03/22/2011 Review Approval
medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators P010031/S178 11/09/2011 Review Approval
medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators P010031/S176 01/09/2012 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
insync iii (model 9981 v8.0) P010015/S166 03/13/2013 Review Approval
consulta crt-p, syncra crt-p P010015/S157 06/04/2012 Review Approval
consulta crt-d/concerto ii crt-d/maximo crt-d icds P010031/S150 04/04/2011 Review Approval
insync crt-p/insync iii crt-p P010015/S107 05/13/2011 Review Approval
insync crt-p & insync iii crt-p P010015/S086 03/22/2011 Review Approval
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization P010015/S084 03/22/2011 Review Approval
lifevest waerable defibrillator P010030/S031 11/02/2012 Review Approval
lifevest wearable defibrillator P010030/S023 04/19/2011 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
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 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
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds P000009/S046 09/30/2011 Review Approval
implantable cv defibrillator/pacemaker programmer/icd monitoring system P000009/S042 04/15/2011 Review Approval
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds P000009/S040 11/26/2010 Review Approval
evia/entovis pulse generators P000009/S035 05/07/2010 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
dema ipg/c & t series ipgs P990001/S082 05/13/2011 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
floseal hemostatic matrix 5 ml/10 ml kit P990009/S025 01/07/2010 Review Approval
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin P990004/S019 05/17/2011 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
concerto, virtuoso (model sw002 v8.0) P980016/S366 03/13/2013 Review Approval
maximo ii df4 icd, secura df4 icd P980016/S362 09/12/2012 Review Approval
maximo ii, secura & virtuoso ii dr/vr icds P980016/S343 06/04/2012 Review Approval
entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii P980016/S298 08/18/2011 Review Approval
protects xt vr, protecta vr, secura vr maximo ii icd P980016/S280 05/02/2012 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
virtuoso ii/secura/maximo ii icds P980016/S273 05/13/2011 Review Approval
advisa dr ipg P980035/S264 06/04/2012 Review Approval
secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds P980016/S240 03/22/2011 Review Approval
enrythm ipg P980016/S237 10/19/2010 Review Approval
medtronic protecta xt dr d314drm, protecta dr d334drm, cardioverter defibrillators P980016/S218 11/09/2011 Review Approval
medtronic secura dr d204drm, maximo ii d264drm, implantable cardioverter defibrillators P980016/S216 01/09/2012 Review Approval
medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators P980016/S211 03/25/2011 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
secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds P980016/S187 04/04/2011 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
entrust icd family P980035/S166 10/19/2010 Review Approval
 
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