age_PMA_annotations  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P990030_S003 Approval of the urological exclusion from the "indications for use" statement. The device, as modified, will be marketed under the trade names costasis/dynastat surgical hemostat and is indicated in 391 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P110019_S066 Approval for the expansion of the indications for use of the xience v and xience nano everolimus eluting coronary stent system xience prime and xience prime ll everolimus eluting coronary stent system 1.31 KB 2020-03-03 11 0
-
DevicePMAs@therightstef P040012_S034 Approval for the rx acculink carotid stent system. The device is indicated for high surgical risk and standard surgical risk patients as follows: high surgical risk -the rx acculink carotid stent sys 1.54 KB 2020-03-03 13 0
-
DevicePMAs@therightstef P120007_S000 Approval for the aptima hpv 16 18/45 genotype assay. aptima hpv 16 18/45 genotype assay indications for use: the aptima hpv 16 18/45 genotype assay is an in vitro nucleic acid amplification test for t 1.9 KB 2020-03-03 13 0
-
DevicePMAs@therightstef P030050_S014 Approval for the revision of a precaution statement in your product label to state: sculptra aesthetic should only be used by a healthcare practitioner trained to correct shallow to deep nasolabial co 823 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P930029_S018 Approval for a cable that will allow a medtronic radio-frequency ablation catheter to function as a diagnostic catheter by providing connectivity to an ep recording system. The device, as modified, w 556 Bytes 2020-03-03 11 0
-
DevicePMAs@therightstef P830063_S000 Approval for the Gambro Fiber Plasmafilter PP. This device is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulation plasma compone 228 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P100009_S000 Approval for the mitraclip clip delivery system (mitraclip cds). this device is indicated for the percutaneous reduction ofsignificant symptomatic mitral regurgitation (mr >= 3+) due to primary abnorm 596 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P000054_S000 Approval for the infuse bone graft. The device is indicated for treating acute, open tibial shaft fractures that have been stabilized with im nail fixation after appropriate wound management. Infuse 321 Bytes 2020-03-03 13 0
-
DevicePMAs@therightstef P120005_S028 For the addition of a bluetooth low energy (ble) radio to both theadult (mt20649) and pediatric (mt22430) versions of the dexcom g4 platinum receiver,identified as the dexcom g4 platinum receiver with 1.3 KB 2020-03-03 11 0
-