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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
implantable cv defibrillator/pacemaker programmer/icd monitoring system P000009/S042 04/15/2011 Review Approval
implantable pacemaker pulse generator,pacemaker programming P950037/S089 04/15/2011 Review Approval
incepta, energen, punctua and cognis crt-d P010012/S255 11/17/2011 Review Approval
incepta, energen, punctua and teligen icds P960040/S235 11/17/2011 Review Approval
instensia icd P980049/S099 11/04/2014   Approval
insync crt-p & insync iii crt-p P010015/S086 03/22/2011 Review Approval
insync crt-p/insync iii crt-p P010015/S107 05/13/2011 Review Approval
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd P010031/S363 05/24/2013 Review Approval
insync ii protect icd, iiimarquis icd, marquis icd, maximo icd, brava crt-d, concerto icd, ii crt-d, consulta icd, maxim P010031/S397 02/14/2014 Review Approval
insync ii protect, insync iii marquis,insync marquis, insync maximo icds P010031/S386 09/27/2013 Review Approval
insync iii (model 9981 v8.0) P010015/S166 03/13/2013 Review Approval
integrity afx dr model 5346 dual chamber pulse generator and programmer software model 3307, v2.2a P880086/S083 07/11/2001   Approval
intensia crt-d P060027/S066 11/04/2014   Approval
intua cardiac resynchronization therapy-pacemaker (crt-p) P030005/S092 05/23/2013 Review Approval
invive v172, v173 P030005/S079 05/01/2012 Review Approval
jewel af icd P980050/S097 10/19/2015 Review Approval
juvederm ultra xc and juvederm ultra plus xc P050047/S005 01/07/2010 Review Approval
kappa 400 dr ipg,kappa 400 sr ipg P970012/S096 10/19/2015 Review Approval
kappa 400 dr/sr ipg P970012/S068 03/22/2011 Review Approval
kappa 400 dr/sr ipgs P970012/S081 05/13/2011 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
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs P980035/S200 05/13/2011 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
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t P050023/S024 05/07/2010 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
latitude nxt 2.0 patient management system P910077/S140 06/20/2014 Review Approval
latitude wave communicator (model 6498) P910077/S119 01/28/2013 Review Approval
lattitude consult system P910077/S138 03/20/2014 Review Approval
lead tunneler model 6888 P830060/S062 11/10/2010 Review Approval
legend plus family of pacemakers P930022/S012 05/13/2011 Review Approval
legend plus ipg P930022/S017 10/19/2015 Review Approval
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds P000009/S046 09/30/2011 Review Approval
lifevest waerable defibrillator P010030/S031 11/02/2012 Review Approval
lifevest wearable defibrillator P010030/S023 04/19/2011 Review Approval
linox smart s65,linox smart sd 65/18,linox s dx 65/15,linox s dx 65/17,protego df-1 s 65,protego df-1 sd 65/18,protego d P980023/S072 12/21/2015 Review  
linox smart steroid-eluting dual-coil icd leads P980023/S038 09/17/2010 Review Approval
linox smart(s65)(sd65/18)(sdx65/15&65/17),protego df-1(s65)(sd65/18)(dx65/15&65/17),protego(s65&75)(sd65/16,65/18,75/18) P950037/S151 12/21/2015 Review  
linox(smart) s dx steroid-eluting single-coil icd leads P980023/S049 02/13/2013 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
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
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
lumax 500/540 icds thoracic impedance P050023/S047 11/17/2011 Review Approval
maximo ii df4 icd, secura df4 icd P980016/S362 09/12/2012 Review Approval
maximo ii dr,maximo ii vr,virtuoso ii vr,secura dr,secura vr P980016/S452 07/09/2014 Review Approval
maximo ii, secura & virtuoso ii dr/vr icds P980016/S343 06/04/2012 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 carelink monitor model 2490c, cardiosight reader P890003/S177 03/25/2011 Review Approval
medtronic carelink monitor model 2490c, cardiosight reader P890003/S181 11/09/2011 Review Approval
medtronic carelink monitor, cardiosight reader P890003/S214 05/02/2012 Review Approval
 
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