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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
evia / entovis family of pulse generators P950037/S091 03/25/2011 Review Approval
evia/entovis/estella/effecta/ecuro P950037/S098 09/30/2011 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
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers P950037/S105 10/03/2012 Review Approval
various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. P950037/S116 03/18/2013 Review Approval
transcyte human fibroblast-derived temporary skin substitute P960007/S021 09/20/2011 Review Approval
spectranetics laser sheath device P960042/S031 04/20/2012 Review Approval
tendril sts lead model 1988tc P960013/S054 04/14/2010 Review Approval
optisense model 1999 lead P960013/S057 11/26/2010 Review Approval
tendril sts 1988tc and 2088tc P960013/S066 11/01/2011 Review Approval
tendril family of leads P960013/S068 09/13/2012 Review Approval
teligen 4-site models P960040/S198 11/10/2010 Review Approval
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
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
kappa 400 dr/sr ipg P970012/S068 03/22/2011 Review Approval
kappa 400 dr/sr ipgs P970012/S081 05/13/2011 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
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
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P980049/S059 09/09/2010 Review Approval
gem iii at P980050/S076 10/26/2012 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
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
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
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin P990004/S019 05/17/2011 Review Approval
floseal hemostatic matrix 5 ml/10 ml kit P990009/S025 01/07/2010 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
 
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