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Documents (3,322) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P060006_S000	Approval for the boston scientific express sd renal monorail premounted stent system. The device is indicated as an adjunct to percutaneous transluminal renal angioplasty (ptra) of a single de novo o	423 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P860019_S149	Approval requested for the SCIMED REMEDY Coronary Balloon Dilatation Infusion Catheter . The device is indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graf	587 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P950002_S007	Approval to add the bp/lordotic to the approved product line for the bak interbody fusion system. The device, as modified, will be marketed under the trade name bp/lordotic and is indicated for use w	719 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P150014_S000	Approval for the cobas hbv. this device is indicated for: cobas hbv is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human edta plasma or serum of	768 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P900033_S033	Approval for a design change to the integra dermal regenerationtemplate. the design change was to produce a meshed version of the integra dermal regeneration template. the device, as modified, will be	734 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P050010_S000	Approval for the prodisc-l total disc replacement. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (ddd) at one level from l3-s1. Ddd is	595 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P910066_S012	Modifications to the sizes of the device. The device, as modified, will be marketed under the trade name Orthologic 1000-SC and is indicated for the noninvasive treatment of an established nonunion a	382 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P100009_S028	Approval for the MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System for expanding the indication to include secondary mitral regurgitation. The devices, when used with maxima	802 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P110040_S000	Approval for the medtronic vascular complete se vascular stent system. this device is indicated to improve luminal diameter in symptomatic patients with de novo and/or restenotic lesions or occlusions	359 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P930016_S045	Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio Indication System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) for Use: in pati	869 Bytes	2020-03-03	13	-