age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P960004_S014	Approval for the silicone and polyurethane thinline(tm) ii sterox and fineline(tm) ii steroid eluting pacing leads. The devices are indicated for chronic pacing and sensing of the ventricle and/or at	249 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P970008_S060	Approval for minor changes to the software for the targis system coolwave control unit model 5000 and associated changes to the user manual. the device,as modified, will be marketed under the trade na	466 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P850020_S011	Approval for the Prosorba(R) Column. This device is indicated for: 1) use in the therapeutic removal of immunoglobulin G (IgG) and IgG-containting circulating immune complexes from plasma in patients	540 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P040005_S005	Approval for the her2 fish pharmdx kit. The device is indicated for in vitro diagnostic use. The her2 fish pharmdx kit is a direct fluorescence in situ hybridization (fish) assay designed to quantit	589 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P960043_S097	Approval for the Perclose ProGlide SMC System which is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagn	599 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P930029_S013	Approval for a new rf generator. The device, as modified, will be marketed under the trade name atakr ii and is indicated for interruption of accessory atrioventricular (av) conduction pathways assoc	389 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P060004_S001	Approval for the mel 80 excimer laser system. This device uses an optical zone of 6.0 to 6.5 mm in diameter and a transition zone of 2.0 to 4.0 mm for a total ablation diameter of 10.0 mm, and is ind	655 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P010040_S002	Approval for clinical use of the device, the components and shielding to minimize emi levels, a higher current capacity for ac operation and two adapters to accommodate destruction of conventional nee	558 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P990080_S000	Approval for the ceeon(tm) edge foldable ultraviolet light-absorbing posterior chamber intraocular lens - model 911a. This device is indicated for primary implantation for the visual correction of ap	365 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P060001_S000	Approval for the protege gps and protege rx carotid stent systems. this device is indicated for used in conjunction with ev3 embolic protection devices, are indicated for the treatment of patients at	665 Bytes	2020-03-03	13	-