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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
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
medtronic carelink monitor, cardiosight reader P890003/S214 05/02/2012 Review Approval
protects xt vr, protecta vr, secura vr maximo ii icd P980016/S280 05/02/2012 Review Approval
invive v172, v173 P030005/S079 05/01/2012 Review Approval
spectranetics laser sheath device P960042/S031 04/20/2012 Review Approval
epic hf/atlas + hf family P030054/S196 03/09/2012 Review Approval
cadence family of icds P910023/S270 03/09/2012 Review Approval
vigila and volta and passive fixation bipolar steroid eluting icd leads P980023/S046 02/22/2012 Review Approval
cellpaker plasma collection device P050044/S019 01/31/2012 Review Approval
medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators P010031/S176 01/09/2012 Review Approval
carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device P890003/S179 01/09/2012 Review Approval
medtronic sprint quattro secure lead model 6947m P920015/S055 01/09/2012 Review Approval
medtronic secura dr d204drm, maximo ii d264drm, implantable cardioverter defibrillators P980016/S216 01/09/2012 Review Approval
endotak reliance is-i passive fixation P910073/S091 01/05/2012 Review Approval
cardiac resynchronization therapy defibrillator (crt-d) P030054/S173 11/29/2011 Review Approval
model 4195 attain starfix lead P060039/S021 11/22/2011 Review Approval
incepta, energen, punctua and cognis crt-d P010012/S255 11/17/2011 Review Approval
lumax 500/540 icds thoracic impedance P050023/S047 11/17/2011 Review Approval
incepta, energen, punctua and teligen icds P960040/S235 11/17/2011 Review Approval
medtronic protecta xt dr d314drm, protecta dr d334drm, cardioverter defibrillators P980016/S218 11/09/2011 Review Approval
medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators P010031/S178 11/09/2011 Review Approval
medtronic carelink monitor model 2490c, cardiosight reader P890003/S181 11/09/2011 Review Approval
tendril sts 1988tc and 2088tc P960013/S066 11/01/2011 Review Approval
radiesse injectable implant P050037/S024 10/31/2011 Review Approval
radiesse injectable implant P050052/S027 10/31/2011 Review Approval
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds P000009/S046 09/30/2011 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
corox otw-l bp leads P070008/S026 09/30/2011 Review Approval
evia/entovis/estella/effecta/ecuro P950037/S098 09/30/2011 Review Approval
transcyte human fibroblast-derived temporary skin substitute P960007/S021 09/20/2011 Review Approval
concerto ii/consulta/insync ii marquis/iii marquis/insync maximo/sentry/maximo ii/protecta/protecta xt P010031/S252 08/18/2011 Review Approval
entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii P980016/S298 08/18/2011 Review Approval
frontier/frontierii/anthem family of crt-ps P030035/S083 08/03/2011 Review Approval
epic hf/atlas + hf family of crt-ds P030054/S189 08/03/2011 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S071 08/03/2011 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 Review Approval
cadence family of icds P910023/S264 08/03/2011 Review Approval
microny family of pacemakers P970013/S040 08/03/2011 Review Approval
restylane injectable gel P040024/S052 07/18/2011 Review Approval
epic hf/atlas+hf/promote/unify families of crt-ds P030054/S181 06/21/2011 Review Approval
cadence/current/fortify families of icds P910023/S257 06/21/2011 Review Approval
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin P990004/S019 05/17/2011 Review Approval
transvene cs/svc lead P980050/S057 05/13/2011 Review Approval
insync crt-p/insync iii crt-p P010015/S107 05/13/2011 Review Approval
dema ipg/c & t series ipgs P990001/S082 05/13/2011 Review Approval
concerto ii/maximo ii/consulta crt-ds P010031/S228 05/13/2011 Review Approval
dual chamber, implantable pulse generator P820003/S104 05/13/2011 Review Approval
medtronic carelink programmer P850051/S074 05/13/2011 Review Approval
medtronics carelink home monitor and cardiosight reader P890003/S211 05/13/2011 Review Approval
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar P900061/S098 05/13/2011 Review Approval
 
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