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.
101 to 150 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
insync ii protect icd, iiimarquis icd, marquis icd, maximo icd, brava crt-d, concerto icd, ii crt-d, consulta icd, maxim | P010031/S397 | 02/14/2014 | Review | Approval |
revo mri ipg | P090013/S112 | 02/14/2014 | 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 |
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 |
consulta crt-p, syncra crt-p | P010015/S215 | 02/14/2014 | Review | Approval |
vitagel surgical hemostat | P050044/S021 | 10/11/2013 | Review | |
mycarelink patient monitor | P890003/S280 | 09/27/2013 | Review | Approval |
insync ii protect, insync iii marquis,insync marquis, insync maximo icds | P010031/S386 | 09/27/2013 | Review | Approval |
entrust,intrinsic 30,intrinsic,marquis dr,marquis vr,maximo dr,maximo vr icds | P980016/S425 | 09/27/2013 | Review | Approval |
revo mri ipg | P090013/S107 | 09/27/2013 | 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 |
consulta crt-p,syncra crt-p | P010015/S208 | 09/27/2013 | Review | Approval |
fineline ii sterox lead | P960004/S060 | 09/09/2013 | Review | Approval |
carelink programmer model 2090 and model 9790/c programmer | P890003/S260 | 09/05/2013 | Review | Approval |
subcutaneous implantable defibrillator (s-icd) system | P110042/S009 | 08/28/2013 | Review | Approval |
reply/esprit sr and dr model pacemakers | P950029/S079 | 06/20/2013 | Review | Approval |
spectranetics laser sheath | P960042/S043 | 06/14/2013 | Review | Approval |
microny family pacemakers | P970013/S054 | 06/06/2013 | Review | Approval |
quadra assura/unify assura family of crt-ds | P030054/S238 | 06/06/2013 | Review | Approval |
ellipse/fortify assura family of icds | P910023/S309 | 06/06/2013 | Review | Approval |
affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S229 | 06/06/2013 | Review | Approval |
frontier/frontier ii/anthem family of crt-ps | P030035/S107 | 06/06/2013 | Review | Approval |
sensolog/dialog/regency family of pacemakers | P880006/S084 | 06/06/2013 | Review | Approval |
versatrax pacing system | P820003/S117 | 05/30/2013 | Review | Approval |
synergyst ii pacing system | P890003/S265 | 05/30/2013 | Review | Approval |
revo mri ipg | P090013/S085 | 05/24/2013 | Review | Approval |
mycarelink patient monitor | P890003/S269 | 05/24/2013 | Review | Approval |
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd | P010031/S363 | 05/24/2013 | 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 and enpulse e1 ipg | P980035/S311 | 05/24/2013 | Review | Approval |
consulta crt-p, syncra crt-p | P010015/S190 | 05/24/2013 | Review | Approval |
intua cardiac resynchronization therapy-pacemaker (crt-p) | P030005/S092 | 05/23/2013 | Review | Approval |
paradym rf crt-d | P060027/S038 | 05/09/2013 | Approval | |
paradym rf vr icds | P980049/S071 | 05/09/2013 | Approval | |
medtronic evera xt dr, evera xt vr, evera s dr, evera s vr implantable cardioverter definrillators | P980016/S382 | 04/03/2013 | Review | Approval |
medtronic carelink monitor, cardiosight reader, carelink express | P890003/S259 | 04/03/2013 | 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 |
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 |
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's | P070008/S036 | 03/18/2013 | 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 |
insync iii (model 9981 v8.0) | P010015/S166 | 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 |
device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) | P890003/S254 | 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 |
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 | P030005/S088 | 03/12/2013 | Review | Approval |
cameron health subcutaneous implantable defibrillator s-icd system | P110042/S002 | 03/07/2013 | Review | Approval |
model 5019 high voltage (hv) splitter/adaptor kit | P920015/S093 | 02/13/2013 | Review | Approval |
linox(smart) s dx steroid-eluting single-coil icd leads | P980023/S049 | 02/13/2013 | 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
-