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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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incepta, energen, punctua and teligen icds P960040/S235 11/17/2011 Review Approval
teligen, incepta, energen and punctua icd devices P960040/S270 11/30/2012 Review Approval
dynagen el & mini icd's; inogen el & mini icd's; origen el & mini icd's; teligen icd P960040/S306 04/11/2014 Review Approval
microny family of pacemakers P970013/S034 03/04/2011 Review Approval
microny family of pacemakers P970013/S038 04/04/2011 Review Approval
microny family of pacemakers P970013/S040 08/03/2011 Review Approval
microny family of pacemakers P970013/S044 05/07/2012 Review Approval
microny family of pacemakers P970013/S050 04/10/2014 Review Approval
microny family pacemakers P970013/S054 06/06/2013 Review Approval
microny family of pacemakers P970013/S057 02/26/2014 Review Approval
microny family of pacemakers P970013/S060 09/12/2014 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 400 dr ipg,kappa 400 sr ipg P970012/S096 10/19/2015 Review Approval
linox smart steroid-eluting dual-coil icd leads P980023/S038 09/17/2010 Review Approval
vigila and volta and passive fixation bipolar steroid eluting icd leads P980023/S046 02/22/2012 Review Approval
linox(smart) s dx steroid-eluting single-coil icd leads P980023/S049 02/13/2013 Review Approval
paradym vr model 8250 & dr model 8550 P980049/S050 04/07/2010 Review Approval
transvene cs/svc lead P980050/S057 05/13/2011 Review Approval
protego family of icd leads P980023/S057 07/03/2014 Review Approval
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P980049/S059 09/09/2010 Review Approval
volta(1cr/2cr/ct/2ct) icd lead, protego (s/sd/t/td) icd lead,kainox vcs 60 icd leadlinox smart (s/sd/t/td/s dx) icd lead P980023/S060 09/16/2014 Review Approval
gem iii at P980050/S076 10/26/2012 Review Approval
jewel af icd P980050/S097 10/19/2015 Review Approval
advisa dr ipg P980035/S134 04/04/2011 Review Approval
medtronics adapta, versa, sensia and relia implantable pulse generator P980035/S150 12/08/2010 Review Approval
xc202 ceramic capacitor P980035/S153 06/18/2010 Review Approval
entrust icd family P980035/S166 10/19/2010 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
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/sensia ipgs P980035/S200 05/13/2011 Review Approval
medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators P980016/S211 03/25/2011 Review Approval
medtronic secura dr d204drm, maximo ii d264drm, implantable cardioverter defibrillators P980016/S216 01/09/2012 Review Approval
medtronic protecta xt dr d314drm, protecta dr d334drm, cardioverter defibrillators P980016/S218 11/09/2011 Review Approval
enrythm ipg P980016/S237 10/19/2010 Review Approval
secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds P980016/S240 03/22/2011 Review Approval
advisa dr ipg P980035/S264 06/04/2012 Review Approval
virtuoso ii/secura/maximo ii icds P980016/S273 05/13/2011 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
entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii P980016/S298 08/18/2011 Review Approval
adapta versa, sensia ipg, advisa dr ipg, advisa dr mri ipg and enpulse e1 ipg P980035/S311 05/24/2013 Review Approval
adapta,versa,sensia,advisa dr,advisa dr mri,enpulse e1,enpulse e2,enrhythm,kappa d(kappa 700),kappa d (kappa 900) ipg, k P980035/S338 09/27/2013 Review Approval
maximo ii, secura & virtuoso ii dr/vr icds P980016/S343 06/04/2012 Review Approval
adapta, versa, sensia ipg, advisa dr ipg, dr mri ipg, enpulse el ipg, e2 ipg, enrhythm ipg, kappa d ipg P980035/S343 02/14/2014 Review Approval
advisa dr,advisa dr mri P980035/S358 07/09/2014 Review Approval
maximo ii df4 icd, secura df4 icd P980016/S362 09/12/2012 Review Approval
concerto, virtuoso (model sw002 v8.0) P980016/S366 03/13/2013 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
medtronic evera xt dr, evera xt vr, evera s dr, evera s vr implantable cardioverter definrillators P980016/S382 04/03/2013 Review Approval