age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
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	-
DevicePMAs@therightstef	P010050_S011	Approval for an automated means of confirmation testing on-board the immulite 2000 immunoassay analyzer. The device, as modified, will be marketed under the trade name immulite 2000 hbsag confirmator	633 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P980035_S035	Approval for the model 2490d carelink monitor and model 2491 ddma software to allow their use with enpulse and kappa devices. The carelink system is indicated for use by a patient to interrogate thei	321 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P010029_S000	Approval for nuflexxa (1% sodium hyaluronate). The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative n	273 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P000029_S013	Approval for performing the protein testing in-house at the q-med quality control laboratory and to change the test method so as to allow for the detection of lower amounts of protein. The device, as	328 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P010012_S026	Approval for the contak cd, contak cd 2, renewal, and renewal 3 devices. These devices are indicated for patients with moderate to severe heart failure (nyha iii/iv) who remain symptomatic despite st	318 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P810002_S049	Approval for the SJM(R) Master Series Aortic Valved Graft with Meadox(R) Hemashield(R) Woven Double Velour Graft, Model CAVGJ-514, in sizes 19, 21, 23, 25, 27, 29, 31, and 33 mm. This device is indic	276 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P930016_S057	Approval for the STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio. This device is indicated for wavefront-guided photorefractive keratectomy (PRK) in patients: 1) with myopia, with or w	868 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P980022_S010	Approval for the guardian telemetered glucose monitoring system (tgms). The device is indicated for continuous or periodic monitoring of interstitial glucose values in persons with diabetes mellitus.	464 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110035_S000	Approval for the epic vascular self-expanding stent system. this device is indicated for the improvement of luminal diameter in patients with de novo or restenotic symptomatic atherosclerotic lesions	322 Bytes	2020-03-03	11	-