age_PMA_annotations  

Documents (2,258) JSON TSV

source DB source ID text size updated at # proj. # Ann. updated_at
DevicePMAs@therightstef P040044_S047 Approval for modifications to the delivery system that composes the mynxgrip vascular closure device. the device, as modified, will be marketed under the trade name mynx ace vascular closure device (" 450 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P040018_S000 Approval for the advia centaur hav igm. Hav igm readypack reagents: this device is indicated for use for the advia centaur hav igm assay and is an in vitro diagnostic immunoassay for the qualitative 793 Bytes 2020-03-03 13 0
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DevicePMAs@therightstef P100039_S001 Approval for the advia centaur anti-hbs2 (ahbs2) assay and adviacentaur anti-hbs2 (ahbs2) quality control material for use on the advia centaur cp instrument. the device, as modified, will be marketed 1.55 KB 2020-03-03 11 0
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DevicePMAs@therightstef P020027_S000 Approval for the dimension fpsa flex reagent cartridge and dimension t/f psa calibrator for dimension rxl and xpand systems. The dimension fpsa flex reagent cartridge is indicated for: the fpsa meth 1.24 KB 2020-03-03 13 0
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DevicePMAs@therightstef P120006_S001 Approval for modifications to the endovascular system, mainly the delivery system, to improve the ease-of-use during deployment. The device, as modified, will be marketed under the trade name ovation 952 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P020022_S000 Approval for the bayer versant hcv rna 3.0 assay (bdna). The device is indicated for: the versant hcv rna 3.0 assay (bdna) is a signal amplification nucleic acid probe assay for the quantitation of 1.09 KB 2020-03-03 11 0
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DevicePMAs@therightstef P060008_S011 Approval to expand the product matrix to include the 38 mm length taxus libert paclitaxel-eluting coronary stent system. The device size will be marketed under the trade name taxus libert long paclit 459 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P180029_S000 Approval for the LOTUS Edge Valve System. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve 563 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P980016_S000 Approval for the Medtronic(R) Model 7271 GEM(TM) DR Dual Chamber Implantable Cardioverter Defibrillator System with Mdoel 9960 (GEM(TM) DR) Application Software, Medtronic(R) Model 6940 CapSureFix(R) 737 Bytes 2020-03-03 11 0
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DevicePMAs@therightstef P900043_S028 Approval for a new indication (elective stenting of de novo and restenotic coronary arteries) and additional stent diameters (4.5 and 5.0 mm) for the bx velocity with hepacoat on stent system. The d 995 Bytes 2020-03-03 11 0
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