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
Name ![Sort by Device Name [A-Z]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon} ![Sort by Device Name [Z-A]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
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PMA
Number
|
Decision
Date
|
Review Memo |
Approval Order |
|---|---|---|---|---|
| frontier/frontierii/anthem family of crt-ps | P030035/S083 | 08/03/2011 | Review | Approval |
| frontier/frontier ii/anthem family of crt-ps | P030035/S089 | 05/07/2012 | Review | Approval |
| frontier/frontier ii family of crt-ps | P030035/S075 | 04/04/2011 | Review | Approval |
| frontier/frontier 2 family of crt-ps | P030035/S070 | 03/04/2011 | Review | Approval |
| fortify dr / vr icd systems | P910023/S226 | 05/07/2010 | Review | Approval |
| floseal hemostatic matrix 5 ml/10 ml kit | P990009/S025 | 01/07/2010 | Review | Approval |
| evia/entovis/estella/effecta/ecuro | P950037/S098 | 09/30/2011 | Review | Approval |
| evia/entovis pulse generators | P070008/S011 | 05/07/2010 | Review | Approval |
| evia/entovis pulse generators | P000009/S035 | 05/07/2010 | Review | Approval |
| evia/entovis dr/dr-t/sr-t & various other models of pulse generators | P950037/S083 | 11/26/2010 | Review | Approval |
| evia / entovis family of pulse generators | P950037/S091 | 03/25/2011 | Review | Approval |
| evia / entovis & various other pulse generators | P950037/S072 | 05/07/2010 | Review | Approval |
| epic hr/atlas + hf family of crt-ds | P030054/S153 | 03/04/2011 | Review | Approval |
| epic hf/atlas+hf/quadra assura/unify assura family of crt-ds | P030054/S206 | 05/07/2012 | Review | Approval |
| epic hf/atlas+hf/promote/unify families of crt-ds | P030054/S181 | 06/21/2011 | Review | Approval |
| epic hf/atlas+hf hamily of crt-ds | P030054/S177 | 04/04/2011 | 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 crt-d system | P030054/S131 | 01/29/2010 | Review | Approval |
| entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii | P980016/S298 | 08/18/2011 | 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 |
| entrust icd family | P980035/S166 | 10/19/2010 | Review | Approval |
| enrythm ipg | P980016/S237 | 10/19/2010 | Review | Approval |
| endotak reliance is-i passive fixation | P910073/S091 | 01/05/2012 | Review | Approval |
| endotak reliance 4-site leads and accessories | P910073/S077 | 11/10/2010 | Review | Approval |
| durata family of leads | P950022/S069 | 01/24/2011 | Review | Approval |
| dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
| device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) | P890003/S254 | 03/13/2013 | Review | Approval |
| dema ipg/c & t series ipgs | P990001/S068 | 03/22/2011 | Review | Approval |
| dema ipg/c & t series ipgs | P990001/S082 | 05/13/2011 | Review | Approval |
| ddma software | P890003/S251 | 09/12/2012 | 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 |
| corox otw-l bp left ventricular pacing lead | P070008/S015 | 12/23/2010 | Review | Approval |
| corox otw-l bp leads | P070008/S026 | 09/30/2011 | Review | Approval |
| consulta crt-p, syncra crt-p | P010015/S157 | 06/04/2012 | Review | Approval |
| 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 |
| consulta crt-d/concerto ii crt-d/maximo crt-d icds | P010031/S150 | 04/04/2011 | Review | Approval |
| consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization | P010015/S084 | 03/22/2011 | Review | Approval |
| concerto, virtuoso (model sw002 v8.0) | P980016/S366 | 03/13/2013 | Review | Approval |
| concerto ii/maximo ii/consulta crt-ds | P010031/S228 | 05/13/2011 | Review | Approval |
| concerto ii/consulta/maximo ii crt-ds | P010031/S198 | 03/22/2011 | 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 |
| 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 |
| concert ii, consulta, & maximo ii crt-ds | P010031/S296 | 06/04/2012 | Review | Approval |
| cognis, incepta, energen and punctua crt-d devices | P010012/S300 | 11/30/2012 | Review | Approval |
| cognis 4-site models | P010012/S212 | 11/10/2010 | Review | Approval |
| cellpaker plasma collection device | P050044/S019 | 01/31/2012 | Review | Approval |
| carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
| carelink monitor & cardiosight reader | P890003/S169 | 04/04/2011 | Review | Approval |
| carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device | P890003/S179 | 01/09/2012 | Review | Approval |
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