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.
101 to 150 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
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 |
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 |
protecta crt-d, protecta df4 crt-d, protecta xt crt-d, protecta xt df4 crt-d | P010031/S314 | 09/10/2012 | Review | |
cognis, incepta, energen and punctua crt-d devices | P010012/S300 | 11/30/2012 | Review | Approval |
concert ii, consulta, & maximo ii crt-ds | P010031/S296 | 06/04/2012 | Review | Approval |
consulta,syncra,viva crt-ps,insync ipg | P010015/S255 | 10/19/2015 | Review | Approval |
incepta, energen, punctua and cognis crt-d | P010012/S255 | 11/17/2011 | 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/maximo ii/consulta crt-ds | P010031/S228 | 05/13/2011 | Review | Approval |
viva crt-p,consulta crt-p,syncra crt-p | P010015/S227 | 07/09/2014 | Review | Approval |
consulta crt-p, syncra crt-p | P010015/S215 | 02/14/2014 | Review | Approval |
cognis 4-site models | P010012/S212 | 11/10/2010 | Review | Approval |
consulta crt-p,syncra crt-p | P010015/S208 | 09/27/2013 | Review | Approval |
concerto ii/consulta/maximo ii crt-ds | P010031/S198 | 03/22/2011 | Review | Approval |
consulta crt-p, syncra crt-p | P010015/S190 | 05/24/2013 | Review | Approval |
medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators | P010031/S178 | 11/09/2011 | Review | Approval |
medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators | P010031/S176 | 01/09/2012 | Review | Approval |
protecta xt crt-d and protecta crt-d implantable cardioverter defibrillators with cardiac resynchronization; model sw009 | P010031/S171 | 03/25/2011 | Review | Approval |
insync iii (model 9981 v8.0) | P010015/S166 | 03/13/2013 | Review | Approval |
consulta crt-p, syncra crt-p | P010015/S157 | 06/04/2012 | Review | Approval |
consulta crt-d/concerto ii crt-d/maximo crt-d icds | P010031/S150 | 04/04/2011 | Review | Approval |
insync crt-p/insync iii crt-p | P010015/S107 | 05/13/2011 | Review | Approval |
insync crt-p & insync iii crt-p | P010015/S086 | 03/22/2011 | Review | Approval |
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization | P010015/S084 | 03/22/2011 | Review | Approval |
lifevest waerable defibrillator | P010030/S031 | 11/02/2012 | Review | Approval |
lifevest wearable defibrillator | P010030/S023 | 04/19/2011 | Review | Approval |
programmer software(1503.u) for ics 3000/renamic programmers | P000009/S063 | 12/21/2015 | Review | |
xelos dr-t icd's | P000009/S057 | 05/04/2014 | 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 |
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 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 |
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds | P000009/S046 | 09/30/2011 | Review | Approval |
implantable cv defibrillator/pacemaker programmer/icd monitoring system | P000009/S042 | 04/15/2011 | Review | Approval |
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds | P000009/S040 | 11/26/2010 | Review | Approval |
evia/entovis pulse generators | P000009/S035 | 05/07/2010 | Review | Approval |
vitatron c20 sr ipg,vitatron c60 dr ipg,vitatron t20 sr ipg,vitatron t60 dr ipg | P990001/S119 | 10/19/2015 | 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 |
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 |
saline-filled and spectrum breast implants | P990075/S051 | 10/27/2021 | Approval | |
natrelle saline filled breast implants | P990074/S045 | 10/27/2021 | Approval | |
floseal hemostatic matrix 5 ml/10 ml kit | P990009/S025 | 01/07/2010 | Review | Approval |
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin | P990004/S019 | 05/17/2011 | Review | Approval |
evera s dr icd, evera s vr icd, evera xt dr icd, evera xt vr icd | P980016/S548 | 10/29/2015 | Review | |
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,gem dr icd,gem ii dr icd, gem ii vr icd,gem iii vr icd,i | P980016/S514 | 10/19/2015 | Review | Approval |
maximo ii dr,maximo ii vr,virtuoso ii vr,secura dr,secura vr | P980016/S452 | 07/09/2014 | 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 |
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,intrinsic 30,intrinsic,marquis dr,marquis vr,maximo dr,maximo vr icds | P980016/S425 | 09/27/2013 | 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
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