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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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PMA
Number
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Decision
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Review
Memo		 Approval
Order
symbios,synergyst ipgs P820003/S132 10/19/2015 Review Approval
synergyst ii pacing system P890003/S265 05/30/2013 Review Approval
teligen 4-site models P960040/S198 11/10/2010 Review Approval
teligen, incepta, energen and punctua icd devices P960040/S270 11/30/2012 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
tendril sts lead model 1988tc P960013/S054 04/14/2010 Review Approval
transcyte human fibroblast-derived temporary skin substitute P960007/S021 09/20/2011 Review Approval
transvene cs/svc lead P980050/S057 05/13/2011 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
unify quadra crt-d, unify quadra assura P030054/S223 08/09/2012 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
various models of lumax icd/crt-d families P050023/S033 11/26/2010 Review Approval
versatrax pacing system P820003/S117 05/30/2013 Review Approval
vigila and volta and passive fixation bipolar steroid eluting icd leads P980023/S046 02/22/2012 Review Approval
virtuoso ii/secura/maximo ii icds P980016/S273 05/13/2011 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
vitagel surgical hemostat P050044/S021 10/11/2013 Review  
vitatron c20 sr ipg,vitatron c60 dr ipg,vitatron t20 sr ipg,vitatron t60 dr ipg P990001/S119 10/19/2015 Review Approval
viva crt-p,consulta crt-p,syncra crt-p P010015/S227 07/09/2014 Review Approval
viva quad xt crt-d,viva quad s crt-d,brava quad crt-d,viva quad c crt-d,viva/brava/evera software application P010031/S442 07/03/2014 Review Approval
volta(1cr/2cr/ct/2ct) icd lead, protego (s/sd/t/td) icd lead,kainox vcs 60 icd leadlinox smart (s/sd/t/td/s dx) icd lead P980023/S060 09/16/2014 Review Approval
xc202 ceramic capacitor P980035/S153 06/18/2010 Review Approval
xelos dr-t icd's P000009/S057 05/04/2014 Review Approval
 
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