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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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transvene cs/svc lead P980050/S057 05/13/2011 Review Approval
paradym vr model 8250 & dr model 8550 P980049/S050 04/07/2010 Review Approval
linox(smart) s dx steroid-eluting single-coil icd leads P980023/S049 02/13/2013 Review Approval
vigila and volta and passive fixation bipolar steroid eluting icd leads P980023/S046 02/22/2012 Review Approval
linox smart steroid-eluting dual-coil icd leads P980023/S038 09/17/2010 Review Approval
kappa 400 dr/sr ipgs P970012/S081 05/13/2011 Review Approval
kappa 400 dr/sr ipg P970012/S068 03/22/2011 Review Approval
microny family of pacemakers P970013/S060 09/12/2014 Review Approval
microny family of pacemakers P970013/S057 02/26/2014 Review Approval
microny family pacemakers P970013/S054 06/06/2013 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/S040 08/03/2011 Review Approval
microny family of pacemakers P970013/S038 04/04/2011 Review Approval
microny family of pacemakers P970013/S034 03/04/2011 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
teligen, incepta, energen and punctua icd devices P960040/S270 11/30/2012 Review Approval
incepta, energen, punctua and teligen icds P960040/S235 11/17/2011 Review Approval
teligen 4-site models P960040/S198 11/10/2010 Review Approval
tendril family of leads P960013/S068 09/13/2012 Review Approval
tendril sts 1988tc and 2088tc P960013/S066 11/01/2011 Review Approval
fineline ii sterox lead P960004/S060 09/09/2013 Review Approval
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
dextrus, selox st/jt, setrox s, and tilda t/jt/r steroid-eluting pacing leads; solox slx -bp pacing lead P950037/S138 09/16/2014 Review Approval
entovis promri pacemaker system P950037/S132 05/04/2014 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 icd's P910023/S342 09/12/2014 Review Approval
ellipse/fortify assura family of icds P910023/S323 02/26/2014 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