age_PMA_annotations  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P880003_S089 Approval for a new catheter model. The device, as modified, will be marketed under the trade name dura star rx ptca balloon dilatation catheter and is indicated for balloon dilatation of the stenotic 432 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P120006_S000 Approval for the ovation abdominal stent graft system. this device is indicated for treatment of patients with abdominalaortic aneurysms having vascular morphology suitable for endovascular repair, in 770 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef N50510_S132 Approval for the addition of the antibiotic chloramphenicol at concentrations of 2, 8 and 16 micrograms/ml to the vitek(r) 2 s. pneumoniae susceptibility test system. The device, as modified, will be 460 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P970020_S036 Approval for the addition of an indication to use the 3.0 mm to 4.0 mm penta(tm) otw and tx for the treatment of svg lesions. The multi-link rx penta and multi-link otw penta coronary stent system wi 1.15 KB 2020-03-03 11 0
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DevicePMAs@therightstef P070014_S000 Approval for the lifestent flexstar and flexstar xl vascular stent system. The device is indicated for improvement of luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up 357 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P880027_S050 Approval for 15 mm length models of the Bonnie(TM) PTCA Catheter. The new models will be marketed under the trade name Bonnie(TM) Monorail(R) Percutaneous Transluminal Coronary Agnioplasty (PTCA) Cat 368 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P010054_S000 Approval for the elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs. The elecsys anti-hbs immunoassay is indicated for: the qualitative determination of total antibodies to the hepatitis 1.25 KB 2020-03-03 11 0
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DevicePMAs@therightstef P990055_S001 Approval for the addition of the assay to the bayer acs: 180 and advia centaur analyzers. The device, as modified, will be marketed under the trade names bayer acs: 180 or advia centaur complexed psa 634 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P030037_S000 Approval for the rithron-xr coronary stent system. The device is indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic heart disease characterized by discrete de no 319 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P970053_S006 Approval to modify the approved claim for the ec-5000 excimer laser system to allow for threatments using an optical zone size of 5.5 mm to 6.5 mm, in addition to the approved optical zone size of t. 517 Bytes 2020-03-03 11 0
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