Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
-
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.
| 151 to 179 of 179 records |
|
|
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}
|
PMA
Number
|
Decision
Date
|
Review Memo |
Approval Order |
|---|---|---|---|---|
| stratos lv/lv-t | P070008/S031 | 10/03/2012 | Review | Approval |
| various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers | P950037/S105 | 10/03/2012 | Review | Approval |
| belos dr/dr-t/vr/vr-t, lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's | P000009/S049 | 10/03/2012 | 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 |
| 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 |
| gem iii at | P980050/S076 | 10/26/2012 | Review | Approval |
| lifevest waerable defibrillator | P010030/S031 | 11/02/2012 | Review | Approval |
| cognis, incepta, energen and punctua crt-d devices | P010012/S300 | 11/30/2012 | Review | Approval |
| teligen, incepta, energen and punctua icd devices | P960040/S270 | 11/30/2012 | Review | Approval |
| anthem, frontier ii crt-ps | P030035/S082 | 12/04/2012 | Review | Approval |
| atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds | P030054/S188 | 12/04/2012 | Review | Approval |
| accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers | P880086/S202 | 12/04/2012 | Review | Approval |
| atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds | P910023/S263 | 12/04/2012 | Review | Approval |
| merlin home 6.1m | P910023/S307 | 12/19/2012 | Review | Approval |
| merlin net 6.1m | P030054/S237 | 12/19/2012 | Review | Approval |
| reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
| latitude wave communicator (model 6498) | P910077/S119 | 01/28/2013 | Review | Approval |
| cameron health subcutaneous implantable defibrillator s-icd system | P110042/S002 | 03/07/2013 | Review | Approval |
| cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 | P030005/S088 | 03/12/2013 | 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 |
| concerto, virtuoso (model sw002 v8.0) | P980016/S366 | 03/13/2013 | Review | Approval |
| kappa 900 (model 9988 v8.0). adapta, versa, sensia (model sw003 v8.0), relia (model sw010 v8.0), enpulse (model 9981 v8. | P980035/S280 | 03/13/2013 | 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 |
| insync iii (model 9981 v8.0) | P010015/S166 | 03/13/2013 | 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 |
| 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 |
| stratos lv/lv-t, evia and entovis hf/hf-t crt-p's | P070008/S036 | 03/18/2013 | Review | Approval |
| various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. | P950037/S116 | 03/18/2013 | Review | Approval |
| belos & lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's | P000009/S051 | 03/18/2013 | Review | Approval |
-
