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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
xc202 ceramic capacitor P980035/S153 06/18/2010 Review Approval
vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) P990001/S105 03/13/2013 Review Approval
virtuoso ii/secura/maximo ii icds P980016/S273 05/13/2011 Review Approval
vigila and volta and passive fixation bipolar steroid eluting icd leads P980023/S046 02/22/2012 Review Approval
versatrax pacing system P820003/S117 05/30/2013 Review Approval
various models of lumax icd/crt-d families P050023/S033 11/26/2010 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
unify quadra crt-d, unify quadra assura P030054/S223 08/09/2012 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
transvene cs/svc lead P980050/S057 05/13/2011 Review Approval
transcyte human fibroblast-derived temporary skin substitute P960007/S021 09/20/2011 Review Approval
tendril sts lead model 1988tc P960013/S054 04/14/2010 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, incepta, energen and punctua icd devices P960040/S270 11/30/2012 Review Approval
teligen 4-site models P960040/S198 11/10/2010 Review Approval
synergyst ii pacing system P890003/S265 05/30/2013 Review Approval
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin P990004/S019 05/17/2011 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S009 08/28/2013 Review Approval
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's P070008/S036 03/18/2013 Review Approval
stratos lv/lv-t crt-p P070008/S017 11/26/2010 Review Approval
stratos lv/lv-t P070008/S031 10/03/2012 Review Approval
stratos lv/lv-t P070008/S019 04/15/2011 Review Approval
stratos lv/lv-t P070008/S028 05/04/2012 Review Approval
st jude medical, merlin psa ex3100 system P030054/S146 05/03/2010 Review Approval
spectranetics laser sheath device P960042/S031 04/20/2012 Review Approval
spectranetics laser sheath P960042/S043 06/14/2013 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S071 08/03/2011 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
sensolog/ dialog/regency family of pacemakers P880006/S081 04/10/2014 Review Approval
senslog/dialog/regency family of pacemakers P880006/S067 03/04/2011 Review Approval
secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds P980016/S240 03/22/2011 Review Approval
secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds P980016/S187 04/04/2011 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
restylane l and perlane l injectable gels P040024/S039 01/29/2010 Review Approval
restylane injectable gel P040024/S052 07/18/2011 Review Approval
reply/esprit sr and dr model pacemakers P950029/S079 06/20/2013 Review Approval
reocor s / d family of external pacemakers P950037/S084 05/08/2012 Review Approval
reliaty/model 3145 pacing system analyzer P950037/S079 09/02/2010 Review Approval
reliaty / model 3145 family of pacing system analyzers P950037/S088 04/20/2011 Review Approval
reliance 4-site defibrillator lead P910073/S107 12/20/2012 Review Approval
radiesse injectable implant P050037/S024 10/31/2011 Review Approval
radiesse injectable implant P050052/S027 10/31/2011 Review Approval
quickflex u model 1258t lead P030054/S130 05/10/2010 Review Approval
quadra assura/unify assura family of crt-ds P030054/S238 06/06/2013 Review Approval
 
 
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