age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P020016_S000	Approval for the total temporomandibular joint replacement system. The device is indicated for reconstruction of the temporomandibular joint. The reconstruction is necessary due to one of the follow	776 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P010012_S000	Approval for the contak cd crt-d system and the easytrak coronary venous steroid-eluding single-electrode pace/sense lead, models 4510, 4511, 4512 and 4513. The contak cd crt-d system is indicated fo	1.56 KB	2020-03-03	11	-
DevicePMAs@therightstef	P130009_S057	Approval for the Edwards SAPIEN XT Transcatheter Heart Valve and accessories for expanding the indication to include patients with intermediate surgical risk for aortic valve replacement. The device i	651 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P040043_S039	Approval for a modified version of the tag thoracic endoprosthesis. the tag device is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate a	368 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P990086_S003	Approval for the healthtronics ossatron. The device is indicated for use for performing extracorporeal shock wave (esw) treatment in patients with chronic lateral epicondylitis (tennis elbow) that ha	408 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P130026_S000	Approval for the tacticath quartz catheter and tactisysquartz equipment. this device is indicated for use in cardiacelectrophysiological mapping and for the treatment of drug refractory recurrent symp	345 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P000014_S019	Approval for revision of the intended use to include use of the vitros 5600integrated system and vitros 3600 immunodiagnostic system with the vitrosimmunodiagnostic products anti-hbs assay. the device	1.57 KB	2020-03-03	11	-
DevicePMAs@therightstef	P990036_S001	Approval for a modification to the existing radiation dosimetry protocol from a protocol that is based on intravascular ultrasound (ivus) to a protocol that prescribes a fixed dose of 14 gy at a dista	491 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P080023_S000	Approval for the architect core reagent kit, architect core calibrator and architect core controls. These devices are indicated for: architect core reagent kit: the architect core assay is a chemilum	1.33 KB	2020-03-03	11	-
DevicePMAs@therightstef	P810046_S230	Approval to modify the protective balloon sheath. The device, as modified, will be marketed under the trade name voyager nc coronary dilatation catheter and is indicated for: 1) balloon dilation of t	526 Bytes	2020-03-03	11	-