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.
251 to 300 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
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 |
concerto ii crt-d,maximo ii crt-d,consulta crt-d,consulta crt-d df4,maximo ii crt-d df4 | P010031/S414 | 07/09/2014 | 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 |
celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead | P070008/S054 | 09/16/2014 | Review | Approval |
carelink programmer model 2090 and model 9790/c programmer | P890003/S260 | 09/05/2013 | Review | Approval |
carelink monitor,cardiosight reader,carelink express,device data management application(ddma) | P890003/S309 | 07/03/2014 | Review | Approval |
carelink monitor, cardiosight reader, carelink express monitor | P890003/S338 | 02/01/2016 | Review | |
carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
carelink monitor and express monitor, cardiosight reader; carelink express | P890003/S329 | 09/11/2015 | Review | |
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 |
carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
carelink enore programmer,carelink 2090 programmer,carelink home monitor,carelink express monitor,cardiosight reader,dev | P890003/S297 | 07/09/2014 | Review | Approval |
carelink device data management application (model 2491) | P890003/S247 | 06/04/2012 | Review | Approval |
carelink ddma software and carelink monitor | P890003/S191 | 10/19/2010 | Review | Approval |
carelink ddma software and carelink monitor | P890003/S192 | 03/22/2011 | Review | Approval |
cardiomems hf pressure measurement system | P100045/S002 | 07/10/2015 | Review | |
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 | P030005/S088 | 03/12/2013 | Review | Approval |
cardiac resynchronization therapy defibrillator (crt-d) | P030054/S173 | 11/29/2011 | Review | Approval |
capsurefix novus mri surescan lead model 5076 | P930039/S130 | 06/22/2015 | Review | |
capsurefix novus mri surescan | P930039/S140 | 02/01/2016 | Review | |
capsurefix mri surescan | P090013/S202 | 02/01/2016 | Review | |
capsure sense lead | P830061/S086 | 02/18/2014 | Review | Approval |
cameron health subcutaneous implantable defibrillator s-icd system | P110042/S002 | 03/07/2013 | Review | Approval |
cadence/ellipse/fortify assura family of icds | P910023/S279 | 05/07/2012 | Review | Approval |
cadence/ellipse/fortify assura family of icd's | P910023/S297 | 04/10/2014 | Review | Approval |
cadence/current/fortify families of icds | P910023/S257 | 06/21/2011 | Review | Approval |
cadence family of icds | P910023/S264 | 08/03/2011 | Review | Approval |
cadence family of icds | P910023/S270 | 03/09/2012 | Review | Approval |
cadence family of icds | P910023/S254 | 04/04/2011 | Review | Approval |
cadence family of icds | P910023/S236 | 03/04/2011 | Review | Approval |
cadence family of icds | P910023/S215 | 01/29/2010 | Review | Approval |
brava,brava quad,concerto ii,consulta,maximo ii,protecta,protecta xt,viva quad s, viva quad xt,viva s, viva xt crt-ds, c | P010031/S478 | 10/19/2015 | Review | Approval |
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software | P010031/S413 | 02/27/2014 | Review | Approval |
brava crt-d, brava quad crt-d, viva quad s crt-d, viva quad xt crt-d, viva s crt-d, viva xt crt-d | P010031/S511 | 10/29/2015 | Review | |
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds | P000009/S040 | 11/26/2010 | Review | Approval |
belos dr/dr-t/vr/vr-t/lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t/xelos dr-t | P000009/S047 | 05/04/2012 | 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 |
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 |
attain starfix lead | P060039/S059 | 09/04/2014 | Review | Approval |
attain performa model 4398 and 4598 left ventricular leads | P080006/S073 | 12/10/2014 | Review | |
attain ability mri , plus mri,straight mri surescan; attain performa mri, straight ans s mri surescan | P080006/S085 | 02/01/2016 | Review | |
attain ability model 4x96 lead | P080006/S063 | 05/15/2014 | Review | Approval |
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds | P910023/S263 | 12/04/2012 | 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
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