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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
paradym vr model 8250 & dr model 8550 P980049/S050 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 crt-d model 8750 P060027/S015 04/07/2010 Review Approval
optisense model 1999 lead P960013/S057 11/26/2010 Review Approval
mycarelink patient monitor P890003/S280 09/27/2013 Review Approval
mycarelink patient monitor P890003/S269 05/24/2013 Review Approval
model 5019 high voltage (hv) splitter/adaptor kit P920015/S093 02/13/2013 Review Approval
model 4195 attain starfix lead P060039/S021 11/22/2011 Review Approval
microny family pacemakers P970013/S054 06/06/2013 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/S034 03/04/2011 Review Approval
microny family of pacemakers P970013/S038 04/04/2011 Review Approval
merlin net 6.1m P030054/S237 12/19/2012 Review Approval
merlin home 6.1m P910023/S307 12/19/2012 Review Approval
medtronics carelink home monitor and cardiosight reader P890003/S211 05/13/2011 Review Approval
medtronics adapta, versa, sensia and relia implantable pulse generator P980035/S150 12/08/2010 Review Approval
medtronic sprint quattro secure lead model 6947m P920015/S055 01/09/2012 Review Approval
medtronic selectsecure lead model 3830 P030036/S004 03/30/2011 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
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 crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators P010031/S178 11/09/2011 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
medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators P010031/S176 01/09/2012 Review Approval
medtronic carelink programmer P850051/S074 05/13/2011 Review Approval
medtronic carelink monitor, cardiosight reader, carelink express P890003/S259 04/03/2013 Review Approval
medtronic carelink monitor, cardiosight reader P890003/S214 05/02/2012 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 attain ability straight model 4396 left ventricular lead P080006/S004 03/31/2011 Review Approval
medtronic attain ability plus model 4296 lead P080006/S002 04/01/2011 Review Approval
maximo ii, secura & virtuoso ii dr/vr icds P980016/S343 06/04/2012 Review Approval
maximo ii df4 icd, secura df4 icd P980016/S362 09/12/2012 Review Approval
lumax 500/540 icds thoracic impedance P050023/S047 11/17/2011 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 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 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
linox(smart) s dx steroid-eluting single-coil icd leads P980023/S049 02/13/2013 Review Approval
linox smart steroid-eluting dual-coil icd leads P980023/S038 09/17/2010 Review Approval
lifevest wearable defibrillator P010030/S023 04/19/2011 Review Approval
lifevest waerable defibrillator P010030/S031 11/02/2012 Review Approval
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds P000009/S046 09/30/2011 Review Approval
legend plus family of pacemakers P930022/S012 05/13/2011 Review Approval
lead tunneler model 6888 P830060/S062 11/10/2010 Review Approval
latitude wave communicator (model 6498) P910077/S119 01/28/2013 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
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t P050023/S024 05/07/2010 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
 
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