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 |
---|---|---|---|---|
ellipse/fortify assura family of icds | P910023/S323 | 02/26/2014 | Review | Approval |
ellipse/fortify assura family of icds | P910023/S309 | 06/06/2013 | Review | Approval |
merlin home 6.1m | P910023/S307 | 12/19/2012 | Review | Approval |
cadence/ellipse/fortify assura family of icd's | P910023/S297 | 04/10/2014 | Review | Approval |
icd family of devices & fortify family of devices | P910023/S295 | 08/09/2012 | Review | Approval |
cadence/ellipse/fortify assura family of icds | P910023/S279 | 05/07/2012 | Review | Approval |
cadence family of icds | P910023/S270 | 03/09/2012 | Review | Approval |
cadence family of icds | P910023/S264 | 08/03/2011 | Review | Approval |
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds | P910023/S263 | 12/04/2012 | Review | Approval |
cadence/current/fortify families of icds | P910023/S257 | 06/21/2011 | Review | Approval |
cadence family of icds | P910023/S254 | 04/04/2011 | Review | Approval |
cadence family of icds | P910023/S236 | 03/04/2011 | Review | Approval |
fortify dr / vr icd systems | P910023/S226 | 05/07/2010 | Review | Approval |
cadence family of icds | P910023/S215 | 01/29/2010 | Review | Approval |
latitude nxt 2.0 patient management system | P910077/S140 | 06/20/2014 | Review | Approval |
model 3140 zoom wireless transmitter and model 3120 zoom latitude programmer/recorder/monitor (prm) | P910077/S139 | 04/11/2014 | Review | Approval |
lattitude consult system | P910077/S138 | 03/20/2014 | Review | Approval |
latitude wave communicator (model 6498) | P910077/S119 | 01/28/2013 | Review | Approval |
reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
endotak reliance is-i passive fixation | P910073/S091 | 01/05/2012 | Review | Approval |
endotak reliance 4-site leads and accessories | P910073/S077 | 11/10/2010 | Review | Approval |
medtronic gem icd,medtronic jewel icd,medtronic jewel plus icd,medtronic micro jewel icd,medtronic micro jewel ii icd,me | P900061/S133 | 10/19/2015 | Review | Approval |
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar | P900061/S098 | 05/13/2011 | Review | Approval |
carelink monitor, cardiosight reader, carelink express monitor | P890003/S338 | 02/01/2016 | Review | |
carelink monitor and express monitor, cardiosight reader; carelink express | P890003/S329 | 09/11/2015 | Review | |
elite,elite ii,minuet,preva,prodigy,thera d,thera dr ipgs, thera id pg,thera ipg,thera s ipg,thera sr ipg,thera vdd ipg, | P890003/S326 | 10/19/2015 | Review | Approval |
carelink monitor,cardiosight reader,carelink express,device data management application(ddma) | P890003/S309 | 07/03/2014 | Review | Approval |
carelink enore programmer,carelink 2090 programmer,carelink home monitor,carelink express monitor,cardiosight reader,dev | P890003/S297 | 07/09/2014 | Review | Approval |
mycarelink monitor, | P890003/S295 | 02/27/2014 | Review | Approval |
mycarelink patient monitor, device data management application, application software | P890003/S285 | 02/14/2014 | Review | Approval |
mycarelink patient monitor | P890003/S280 | 09/27/2013 | Review | Approval |
mycarelink patient monitor | P890003/S269 | 05/24/2013 | Review | Approval |
synergyst ii pacing system | P890003/S265 | 05/30/2013 | Review | Approval |
carelink programmer model 2090 and model 9790/c programmer | P890003/S260 | 09/05/2013 | Review | Approval |
medtronic carelink monitor, cardiosight reader, carelink express | P890003/S259 | 04/03/2013 | 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 |
ddma software | P890003/S251 | 09/12/2012 | Review | Approval |
carelink device data management application (model 2491) | P890003/S247 | 06/04/2012 | Review | Approval |
medtronic carelink monitor, cardiosight reader | P890003/S214 | 05/02/2012 | Review | Approval |
medtronics carelink home monitor and cardiosight reader | P890003/S211 | 05/13/2011 | Review | Approval |
carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
carelink ddma software and carelink monitor | P890003/S192 | 03/22/2011 | Review | Approval |
carelink ddma software and carelink monitor | P890003/S191 | 10/19/2010 | Review | Approval |
carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
medtronic carelink monitor model 2490c, cardiosight reader | P890003/S181 | 11/09/2011 | Review | Approval |
carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device | P890003/S179 | 01/09/2012 | Review | Approval |
medtronic carelink monitor model 2490c, cardiosight reader | P890003/S177 | 03/25/2011 | Review | Approval |
carelink monitor & cardiosight reader | P890003/S169 | 04/04/2011 | Review | Approval |
affinity/integrity / victory /zephyr accent family of pacemakers | P880086/S255 | 08/27/2015 | Review | |
affinity, integrity, victory, zephyr, & accent family of pacemakers | P880086/S245 | 09/12/2014 | 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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