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.
151 to 200 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds | P980016/S187 | 04/04/2011 | Review | Approval |
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs | P980035/S200 | 05/13/2011 | Review | Approval |
medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators | P980016/S211 | 03/25/2011 | Review | Approval |
medtronic secura dr d204drm, maximo ii d264drm, implantable cardioverter defibrillators | P980016/S216 | 01/09/2012 | Review | Approval |
medtronic protecta xt dr d314drm, protecta dr d334drm, cardioverter defibrillators | P980016/S218 | 11/09/2011 | Review | Approval |
enrythm ipg | P980016/S237 | 10/19/2010 | Review | Approval |
secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds | P980016/S240 | 03/22/2011 | Review | Approval |
advisa dr ipg | P980035/S264 | 06/04/2012 | Review | Approval |
virtuoso ii/secura/maximo ii icds | P980016/S273 | 05/13/2011 | Review | Approval |
protects xt vr, protecta vr, secura vr maximo ii icd | P980016/S280 | 05/02/2012 | 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 |
entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii | P980016/S298 | 08/18/2011 | Review | Approval |
adapta versa, sensia ipg, advisa dr ipg, advisa dr mri ipg and enpulse e1 ipg | P980035/S311 | 05/24/2013 | Review | Approval |
adapta,versa,sensia,advisa dr,advisa dr mri,enpulse e1,enpulse e2,enrhythm,kappa d(kappa 700),kappa d (kappa 900) ipg, k | P980035/S338 | 09/27/2013 | Review | Approval |
adapta, versa, sensia ipg, advisa dr ipg, dr mri ipg, enpulse el ipg, e2 ipg, enrhythm ipg, kappa d ipg | P980035/S343 | 02/14/2014 | Review | Approval |
maximo ii, secura & virtuoso ii dr/vr icds | P980016/S343 | 06/04/2012 | Review | Approval |
advisa dr,advisa dr mri | P980035/S358 | 07/09/2014 | Review | Approval |
protecta df4 icd, protecta icd, protecta xt df4 icd, protecta xt icd | P980016/S361 | 09/10/2012 | Review | |
maximo ii df4 icd, secura df4 icd | P980016/S362 | 09/12/2012 | Review | Approval |
concerto, virtuoso (model sw002 v8.0) | P980016/S366 | 03/13/2013 | 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 |
medtronic evera xt dr, evera xt vr, evera s dr, evera s vr implantable cardioverter definrillators | P980016/S382 | 04/03/2013 | 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 |
adapta,versa,sensia ipg,advisa dr ipg,advisa dr mri ipg,at500 dddrp pacing system ipg, enpulse e2 ipg,enpulse e2 ipg,kap | P980035/S404 | 10/19/2015 | Review | Approval |
advisa sr ipg | P980035/S424 | 06/22/2015 | Review | |
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 |
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 |
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,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 | |
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin | P990004/S019 | 05/17/2011 | Review | Approval |
floseal hemostatic matrix 5 ml/10 ml kit | P990009/S025 | 01/07/2010 | Review | Approval |
natrelle saline filled breast implants | P990074/S045 | 10/27/2021 | Approval | |
saline-filled and spectrum breast implants | P990075/S051 | 10/27/2021 | 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 |
vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) | P990001/S105 | 03/13/2013 | 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 |
evia/entovis pulse generators | P000009/S035 | 05/07/2010 | Review | Approval |
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds | P000009/S040 | 11/26/2010 | Review | Approval |
implantable cv defibrillator/pacemaker programmer/icd monitoring system | P000009/S042 | 04/15/2011 | Review | Approval |
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds | P000009/S046 | 09/30/2011 | 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 |
xelos dr-t icd's | P000009/S057 | 05/04/2014 | Review | Approval |
programmer software(1503.u) for ics 3000/renamic programmers | P000009/S063 | 12/21/2015 | Review | |
lifevest wearable defibrillator | P010030/S023 | 04/19/2011 | 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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