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 |
---|---|---|---|---|
unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | Review | Approval |
protecta crt-d, protecta df4 crt-d, protecta xt crt-d, protecta xt df4 crt-d | P010031/S314 | 09/10/2012 | Review | |
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 |
ddma software | P890003/S251 | 09/12/2012 | Review | Approval |
tendril family of leads | P960013/S068 | 09/13/2012 | Review | Approval |
durata leads | P950022/S079 | 09/13/2012 | Approval | |
stratos lv/lv-t | P070008/S031 | 10/03/2012 | Review | Approval |
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers | P950037/S105 | 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 icd's | P000009/S049 | 10/03/2012 | Review | Approval |
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's | P050023/S053 | 10/03/2012 | 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 |
gem iii at | P980050/S076 | 10/26/2012 | 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 |
lifevest waerable defibrillator | P010030/S031 | 11/02/2012 | Review | Approval |
teligen, incepta, energen and punctua icd devices | P960040/S270 | 11/30/2012 | Review | Approval |
cognis, incepta, energen and punctua crt-d devices | P010012/S300 | 11/30/2012 | Review | Approval |
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers | P880086/S202 | 12/04/2012 | Review | Approval |
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds | P910023/S263 | 12/04/2012 | Review | Approval |
anthem, frontier ii crt-ps | P030035/S082 | 12/04/2012 | Review | Approval |
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds | P030054/S188 | 12/04/2012 | Review | Approval |
merlin home 6.1m | P910023/S307 | 12/19/2012 | Review | Approval |
merlin net 6.1m | P030054/S237 | 12/19/2012 | Review | Approval |
reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
latitude wave communicator (model 6498) | P910077/S119 | 01/28/2013 | Review | Approval |
linox(smart) s dx steroid-eluting single-coil icd leads | P980023/S049 | 02/13/2013 | Review | Approval |
model 5019 high voltage (hv) splitter/adaptor kit | P920015/S093 | 02/13/2013 | Review | Approval |
cameron health subcutaneous implantable defibrillator s-icd system | P110042/S002 | 03/07/2013 | Review | Approval |
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 | P030005/S088 | 03/12/2013 | 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 |
insync iii (model 9981 v8.0) | P010015/S166 | 03/13/2013 | 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 |
vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) | P990001/S105 | 03/13/2013 | Review | Approval |
concerto, virtuoso (model sw002 v8.0) | P980016/S366 | 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 |
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 |
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 |
paradym rf crt-d | P060027/S038 | 05/09/2013 | Approval | |
paradym rf vr icds | P980049/S071 | 05/09/2013 | Approval | |
intua cardiac resynchronization therapy-pacemaker (crt-p) | P030005/S092 | 05/23/2013 | Review | Approval |
mycarelink patient monitor | P890003/S269 | 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 |
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd | P010031/S363 | 05/24/2013 | Review | Approval |
revo mri ipg | P090013/S085 | 05/24/2013 | 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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