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Documents (3,322) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P010049_S010	Approval to modify the design of the quickseal arterial closure system to allow the delivery of q-foam hemostatic sponge through an introducer delivery sheath and eliminate the depth market component.	758 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P080029_S000	Approval for the quick-close vascular suturing system. this device is indicated as follows: the quick-close vascular suturing system is indicated to close femoral artery accesssites and to reduce time	663 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P040044_S000	Approval for the matrix vsg system, model mx-100. The device is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergon	299 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P920004_S015	Approval to modify language in the instructions for use (ifu) for the vasoseal ea and vasoseal vhd devices to add clinical study data to the labeling for both devices in support of a new claim for red	1.16 KB	2020-03-03	13	-
DevicePMAs@therightstef	P930038_S052	Approval for use of the angio-seal vascular closure device in closure of femoral venous puncture sites and for the removal of the precaution statement relating to the use of the anticoagulant warfarin	598 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P040044_S011	Approval for minor design changes to the 6f/7f mynx vascular closure device. The device, as modified, will be marketed under the trade name m5 mynx vascular closure device and is indicated for use to	403 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P990037_S001	Approval for the change in diluent and procoagulant components. The device, as modified, will be marketed under the trade name diagnostic duett and is indicated for sealing femoral arterial puncture	414 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P960043_S080	Approval for the perclose proglide suture mediated closure system. this device is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patientswho hav	389 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P920004_S017	Approval to market a smaller version of the vasoseal vhd device. The device, as modified, will be marketed under the trade name vasoseal 4-5 french system and is indicated for "use in sealing the fem	525 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P050043_S002	Approval for the addition of the 7f fish-sp device to the fish product line. The device, as modified, will be marketed under the trade name 7f fish-sp device for closure and is indicated for percutan	412 Bytes	2020-03-03	13	-