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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
consulta crt-p, advisa (model 9995 v8.0) consulta crt-d, secura (model 9995 v8.0) insync iii, maximo ii, concerto ii P010031/S319 03/13/2013 Review Approval
concerta, consulta/consulta df4, & various insync families of icd's; concerto ii, maximo ii,protecta,protecta xt crt-d's P010031/S329 10/26/2012 Review Approval
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd P010031/S363 05/24/2013 Review Approval
insync ii protect, insync iii marquis,insync marquis, insync maximo icds P010031/S386 09/27/2013 Review Approval
medtronic selectsecure lead model 3830 P030036/S004 03/30/2011 Review Approval
frontier/frontier 2 family of crt-ps P030035/S070 03/04/2011 Review Approval
frontier/frontier ii family of crt-ps P030035/S075 04/04/2011 Review Approval
invive v172, v173 P030005/S079 05/01/2012 Review Approval
anthem, frontier ii crt-ps P030035/S082 12/04/2012 Review Approval
frontier/frontierii/anthem family of crt-ps P030035/S083 08/03/2011 Review Approval
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 P030005/S088 03/12/2013 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S089 05/07/2012 Review Approval
intua cardiac resynchronization therapy-pacemaker (crt-p) P030005/S092 05/23/2013 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S107 06/06/2013 Review Approval
quickflex u model 1258t lead P030054/S130 05/10/2010 Review Approval
epic hf crt-d system P030054/S131 01/29/2010 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
st jude medical, merlin psa ex3100 system P030054/S146 05/03/2010 Review Approval
epic hr/atlas + hf family of crt-ds P030054/S153 03/04/2011 Review Approval
cardiac resynchronization therapy defibrillator (crt-d) P030054/S173 11/29/2011 Review Approval
epic hf/atlas+hf hamily of crt-ds P030054/S177 04/04/2011 Review Approval
epic hf/atlas+hf/promote/unify families of crt-ds P030054/S181 06/21/2011 Review Approval
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
epic hf/atlas + hf family of crt-ds P030054/S189 08/03/2011 Review Approval
epic hf/atlas + hf family P030054/S196 03/09/2012 Review Approval
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds P030054/S206 05/07/2012 Review Approval
unify quadra crt-d, unify quadra assura P030054/S223 08/09/2012 Review Approval
merlin net 6.1m P030054/S237 12/19/2012 Review Approval
quadra assura/unify assura family of crt-ds P030054/S238 06/06/2013 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
juvederm ultra xc and juvederm ultra plus xc P050047/S005 01/07/2010 Review Approval
cellpaker plasma collection device P050044/S019 01/31/2012 Review Approval
radiesse injectable implant P050037/S024 10/31/2011 Review Approval
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t P050023/S024 05/07/2010 Review Approval
radiesse injectable implant P050052/S027 10/31/2011 Review Approval
various models of lumax icd/crt-d families P050023/S033 11/26/2010 Review Approval
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t P050023/S039 04/15/2011 Review Approval
lumax 300/340 vr-t/dr-t/hf-t/lumax 500/540 vr-t/dr-t/hf-t/lumax 540 vr-t dx P050023/S046 09/30/2011 Review Approval
lumax 500/540 icds thoracic impedance P050023/S047 11/17/2011 Review Approval
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t P050023/S048 05/04/2012 Review Approval
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's P050023/S053 10/03/2012 Review Approval
ilesto 7/ 5 vr-t icd, iforia 7/ 5 vr-t icd, ilesto 7/ 5 vr-t dx icd, ilforia 7/ 5 vr-t dx icd, ilesto 7/ 5 dr-t icd P050023/S058 03/18/2013 Review Approval
paradym crt-d model 8750 P060027/S015 04/07/2010 Review Approval
model 4195 attain starfix lead P060039/S021 11/22/2011 Review Approval
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P060027/S026 09/09/2010 Review Approval
evia/entovis pulse generators P070008/S011 05/07/2010 Review Approval
corox otw-l bp left ventricular pacing lead P070008/S015 12/23/2010 Review Approval
stratos lv/lv-t crt-p P070008/S017 11/26/2010 Review Approval
stratos lv/lv-t P070008/S019 04/15/2011 Review Approval
 
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