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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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Device
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PMA
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Decision
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Review
Memo
Approval
Order
medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators P980016/S211 03/25/2011 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 selectsecure lead model 3830 P030036/S004 03/30/2011 Review Approval
medtronic sprint quattro secure lead model 6947m P920015/S055 01/09/2012 Review Approval
medtronics adapta, versa, sensia and relia implantable pulse generator P980035/S150 12/08/2010 Review Approval
medtronics carelink home monitor and cardiosight reader P890003/S211 05/13/2011 Review Approval
merlin home 6.1m P910023/S307 12/19/2012 Review Approval
merlin net 6.1m P030054/S237 12/19/2012 Review Approval
microny family of pacemakers P970013/S040 08/03/2011 Review Approval
microny family of pacemakers P970013/S050 04/10/2014 Review Approval
microny family of pacemakers P970013/S044 05/07/2012 Review Approval
microny family of pacemakers P970013/S038 04/04/2011 Review Approval
microny family of pacemakers P970013/S034 03/04/2011 Review Approval
microny family pacemakers P970013/S054 06/06/2013 Review Approval
model 3140 zoom wireless transmitter and model 3120 zoom latitude programmer/recorder/monitor (prm) P910077/S139 04/11/2014 Review Approval
model 4195 attain starfix lead P060039/S021 11/22/2011 Review Approval
model 5019 high voltage (hv) splitter/adaptor kit P920015/S093 02/13/2013 Review Approval
mycarelink monitor, P890003/S295 02/27/2014 Review Approval
mycarelink patient monitor P890003/S269 05/24/2013 Review Approval
mycarelink patient monitor P890003/S280 09/27/2013 Review Approval
mycarelink patient monitor, device data management application, application software P890003/S285 02/14/2014 Review Approval
optisense model 1999 lead P960013/S057 11/26/2010 Review Approval
paradym crt-d model 8750 P060027/S015 04/07/2010 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
paradym vr model 8250 & dr model 8550 P980049/S050 04/07/2010 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
protects xt vr, protecta vr, secura vr maximo ii icd P980016/S280 05/02/2012 Review Approval
quadra assura/unify assura family of crt-ds P030054/S238 06/06/2013 Review Approval
quickflex u model 1258t lead P030054/S130 05/10/2010 Review Approval
radiesse injectable implant P050037/S024 10/31/2011 Review Approval
radiesse injectable implant P050052/S027 10/31/2011 Review Approval
reliance 4-site defibrillator lead P910073/S107 12/20/2012 Review Approval
reliaty / model 3145 family of pacing system analyzers P950037/S088 04/20/2011 Review Approval
reliaty/model 3145 pacing system analyzer P950037/S079 09/02/2010 Review Approval
reocor s / d family of external pacemakers P950037/S084 05/08/2012 Review Approval
reply/esprit sr and dr model pacemakers P950029/S079 06/20/2013 Review Approval
restylane injectable gel P040024/S052 07/18/2011 Review Approval
restylane l and perlane l injectable gels P040024/S039 01/29/2010 Review Approval
revo mri ipg P090013/S112 02/14/2014 Review Approval
revo mri ipg P090013/S085 05/24/2013 Review Approval
revo mri ipg P090013/S107 09/27/2013 Review Approval
secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds P980016/S187 04/04/2011 Review Approval
secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds P980016/S240 03/22/2011 Review Approval
senslog/dialog/regency family of pacemakers P880006/S067 03/04/2011 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S081 04/10/2014 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S075 05/07/2012 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S084 06/06/2013 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S070 04/04/2011 Review Approval
 
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