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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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Review
Memo
Approval
Order
optisense model 1999 lead P960013/S057 11/26/2010 Review Approval
tendril sts lead model 1988tc P960013/S054 04/14/2010 Review Approval
spectranetics laser sheath P960042/S043 06/14/2013 Review Approval
spectranetics laser sheath device P960042/S031 04/20/2012 Review Approval
transcyte human fibroblast-derived temporary skin substitute P960007/S021 09/20/2011 Review Approval
various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. P950037/S116 03/18/2013 Review Approval
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers P950037/S105 10/03/2012 Review Approval
cylos/dr/dr-t/vr/dromos dr/sr/sl/kairos dr/sr/sl/d/s/philos/dr/dr-t/sr/slr/d/s/philos ii d/dr/s/slr/sr/dr-t/protos dr/cl P950037/S100 05/04/2012 Review Approval
evia/entovis/estella/effecta/ecuro P950037/S098 09/30/2011 Review Approval
evia / entovis family of pulse generators P950037/S091 03/25/2011 Review Approval
implantable pacemaker pulse generator,pacemaker programming P950037/S089 04/15/2011 Review Approval
reliaty / model 3145 family of pacing system analyzers P950037/S088 04/20/2011 Review Approval
reocor s / d family of external pacemakers P950037/S084 05/08/2012 Review Approval
evia/entovis dr/dr-t/sr-t & various other models of pulse generators P950037/S083 11/26/2010 Review Approval
reliaty/model 3145 pacing system analyzer P950037/S079 09/02/2010 Review Approval
reply/esprit sr and dr model pacemakers P950029/S079 06/20/2013 Review Approval
evia / entovis & various other pulse generators P950037/S072 05/07/2010 Review Approval
durata family of leads P950022/S069 01/24/2011 Review Approval
legend plus family of pacemakers P930022/S012 05/13/2011 Review Approval
model 5019 high voltage (hv) splitter/adaptor kit P920015/S093 02/13/2013 Review Approval
medtronic sprint quattro secure lead model 6947m P920015/S055 01/09/2012 Review Approval
ellipse/fortify assura family of icds P910023/S309 06/06/2013 Review Approval
merlin home 6.1m P910023/S307 12/19/2012 Review Approval
cadence/ellipse/fortify assura family of icd's P910023/S297 04/10/2014 Review Approval
icd family of devices & fortify family of devices P910023/S295 08/09/2012 Review Approval
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
cadence family of icds P910023/S270 03/09/2012 Review Approval
cadence family of icds P910023/S264 08/03/2011 Review Approval
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds P910023/S263 12/04/2012 Review Approval
cadence/current/fortify families of icds P910023/S257 06/21/2011 Review Approval
cadence family of icds P910023/S254 04/04/2011 Review Approval
cadence family of icds P910023/S236 03/04/2011 Review Approval
fortify dr / vr icd systems P910023/S226 05/07/2010 Review Approval
cadence family of icds P910023/S215 01/29/2010 Review Approval
model 3140 zoom wireless transmitter and model 3120 zoom latitude programmer/recorder/monitor (prm) P910077/S139 04/11/2014 Review Approval
lattitude consult system P910077/S138 03/20/2014 Review Approval
latitude wave communicator (model 6498) P910077/S119 01/28/2013 Review Approval
reliance 4-site defibrillator lead P910073/S107 12/20/2012 Review Approval
endotak reliance is-i passive fixation P910073/S091 01/05/2012 Review Approval
endotak reliance 4-site leads and accessories P910073/S077 11/10/2010 Review Approval
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar P900061/S098 05/13/2011 Review Approval
mycarelink monitor, P890003/S295 02/27/2014 Review Approval
mycarelink patient monitor, device data management application, application software P890003/S285 02/14/2014 Review Approval
mycarelink patient monitor P890003/S280 09/27/2013 Review Approval
mycarelink patient monitor P890003/S269 05/24/2013 Review Approval
synergyst ii pacing system P890003/S265 05/30/2013 Review Approval
carelink programmer model 2090 and model 9790/c programmer P890003/S260 09/05/2013 Review Approval
medtronic carelink monitor, cardiosight reader, carelink express P890003/S259 04/03/2013 Review Approval
device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) P890003/S254 03/13/2013 Review Approval
ddma software P890003/S251 09/12/2012 Review Approval
 
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