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.
201 to 250 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
evia / entovis & various other pulse generators | P950037/S072 | 05/07/2010 | Review | Approval |
evera s dr icd,evera s vr icd, evera xt dr icd,evera xt vr icd, viva/brava/evera programmer application software | P980016/S451 | 02/27/2014 | Review | Approval |
evera s dr icd, evera s vr icd,evera xt dr icd, evera xt vr icd,gem dr icd,gem ii dr icd, gem ii vr icd,gem iii vr icd,i | P980016/S514 | 10/19/2015 | Review | Approval |
evera mri xt dr, xt vr, s dr, s vr surescan icd's | P980016/S536 | 09/11/2015 | Review | |
evera s dr icd, evera s vr icd, evera xt dr icd, evera xt vr icd | P980016/S548 | 10/29/2015 | Review | |
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/quandra assura/unify assura family of crt-d's | P030054/S226 | 04/10/2014 | 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,intrinsic 30,intrinsic,marquis dr,marquis vr,maximo dr,maximo vr icds | P980016/S425 | 09/27/2013 | Review | Approval |
entrust icd, intrinsic 30icd, marquis dr icd, vr icd, maximo dr icd, vr icd, evera s dr icd, s vr icd,xt vr icd, maximo | P980016/S436 | 02/14/2014 | Review | Approval |
entrust icd, intrinsic 30 icd, intrinsic icd, intrinsic icd, marquis dr icd, marquis vr icd, maximo dr icd, maximo vr ic | P980016/S400 | 05/24/2013 | Review | Approval |
entrust icd family | P980035/S166 | 10/19/2010 | Review | Approval |
entovis promri pacemaker system | P950037/S132 | 05/04/2014 | 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 |
ellipse/fortify assura family of icds | P910023/S323 | 02/26/2014 | Review | Approval |
ellipse/fortify assura family of icds | P910023/S309 | 06/06/2013 | Review | Approval |
ellipse/fortify assura family of icd's | P910023/S355 | 08/27/2015 | Review | |
ellipse / fortify assura family of icd's | P910023/S342 | 09/12/2014 | Review | Approval |
elite,elite ii,minuet,preva,prodigy,thera d,thera dr ipgs, thera id pg,thera ipg,thera s ipg,thera sr ipg,thera vdd ipg, | P890003/S326 | 10/19/2015 | Review | Approval |
dynagen el & mini icd's; inogen el & mini icd's; origen el & mini icd's; teligen icd | P960040/S306 | 04/11/2014 | Review | Approval |
dynagen & dynagen x4 crt-d's; inogen & inogen x4 crt-d's; origen & origen x4 crt-d's; cognis crt-d | P010012/S341 | 04/11/2014 | Review | Approval |
durata leads | P950022/S079 | 09/13/2012 | Approval | |
durata family of leads | P950022/S069 | 01/24/2011 | Review | Approval |
dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
dextrus, selox st/jt, setrox s, and tilda t/jt/r steroid-eluting pacing leads; solox slx -bp pacing lead | P950037/S138 | 09/16/2014 | 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/S082 | 05/13/2011 | Review | Approval |
dema ipg/c & t series ipgs | P990001/S068 | 03/22/2011 | 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,syncra,viva crt-ps,insync ipg | P010015/S255 | 10/19/2015 | Review | Approval |
consulta crt-p,syncra crt-p | P010015/S208 | 09/27/2013 | Review | Approval |
consulta crt-p, syncra crt-p | P010015/S215 | 02/14/2014 | Review | Approval |
consulta crt-p, syncra crt-p | P010015/S190 | 05/24/2013 | 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 |
Other Databases
- 510(k)s
- De Novo
- Medical Device Reports (MAUDE)
- CDRH Export Certificate Validation (CECV)
- CDRH FOIA Electronic Reading Room
- CFR Title 21
- CLIA
- Device Classification
- FDA Guidance Documents
- Humanitarian Device Exemption
- Medsun Reports
- Premarket Approvals (PMAs)
- Post-Approval Studies
- Postmarket Surveillance Studies
- Radiation-Emitting Products
- Radiation-Emitting Electronic Products Corrective Actions
- Recalls
- Registration & Listing
- Standards
- Total Product Life Cycle
- X-Ray Assembler
-