age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P040034_S013	Approval to identify alternate applicators for use with the device. The device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.	192 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P030027_S000	Approval for the transcend hip articulation system. The device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as o	285 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P930016_S031	Approval for modification of the starpatient's chair. the device, as modified, will he marketed under the trade name star s4ir excimer laser system and is indicated for wave front-guided (wfg) laser a	954 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P050034_S000	Approval for the imt models wide angle 2.2x and wide angle 2.7x. this device is indicated for monocularimplantation to improve vision in patients greater than or equal to 75 years of age with stablese	1.09 KB	2020-03-03	13	-
DevicePMAs@therightstef	P040046_S000	Approval for the natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants. this device is indicated for women for the following uses (procedures):1) breast augmentation for wom	776 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P970019_S000	Approval for the lithotron(tm) lithotripsy system. This device is indicated for use in patients with renal and upper ureteral calculi between 4 and 20 mm in size.	163 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P960039_S000	Approval for the soft-55 ew aphakic (vifilcon a) soft (hydrophilic) contact lenses for extended wear. This device is indicated for extended wear from 1 to 7 days between removals for cleaning and dis	536 Bytes	2020-03-03	11	-
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	P910066_S004	Approval for the orthologic 1000 single closed coil soft pack bone growth stimulator in sizes xs, s, m, l, and xl and for the orthologic 1000 bone growth stimulator in the medium size. The devices, a	524 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P010030_S063	Approval for v07.5 monitor software which includes nine software changes to the lifevest wearabledefibrillator 4000 monitor, the device, as modified, will be marketed under the trade name lifevest wea	368 Bytes	2020-03-03	13	-