PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P990027_S000	Approval for the technolas(r) 217a excimer laser system. The devices is indicated to perform laser in-situ keratomileusis (lasik): 1) in treatments for the reduction or eliminatino of myopia (nearsi	528 Bytes	2020-03-03	13	13	-
DevicePMAs@therightstef	P960016_S000	Approval for the Livewire TC(TM) Cardiac Ablation System. The device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory at	450 Bytes	2020-03-03	11	25	-
DevicePMAs@therightstef	P980016_S029	Approval for medtronic models 7230cx, 7230b, and 7230e marquis vr single chamber implantable cardioverter defibrillator (icd) systems with model 9967 (marquis vr) application software for use with the	885 Bytes	2020-03-03	11	27	-
DevicePMAs@therightstef	P830055_S067	Approval for several sizes of newly developed trochlear groove implants to be used in conjunction with currently marketed patellar componenets of the LCS Total Knee System for the purpose of resurfaci	503 Bytes	2020-03-03	11	14	-
DevicePMAs@therightstef	P010033_S011	Approval for a modification of the quantiferon - tb gold to an in-tube collection system that consists of three blood collection tubes, nil, tb antigen, and mitogen. The device, as modified, will be	692 Bytes	2020-03-03	13	29	-
DevicePMAs@therightstef	P000010_S000	Approval for the amplicor hepatitis c virus (hcv) test, v2.0. The device is indicated for: the qualitative detection of hcv rna in human serum or plasma from blood collected in edta (edta plasma). T	797 Bytes	2020-03-03	11	39	-
DevicePMAs@therightstef	N50510_S110	Approval is for the addition of the antibiotic norfloxacin at concentrations of 0.5, 1 and 4ug/ml to the Vitek 2 Gram Positive Susceptibility Test System. The device, as modified, will be marketed un	408 Bytes	2020-03-03	13	19	-
DevicePMAs@therightstef	P950022_S028	Approval for: 1) modifications to the riata st models 7000, 7001 and 7002 active-fixation defibrillation leads to change the geometric profile of the inner coil and add white pigment to the medical ad	920 Bytes	2020-03-03	11	22	-
DevicePMAs@therightstef	P030025_S028	Approval for the taxus express2 paclitaxel-eluting coronary stent system in-stent restenosis (isr) indication. The device is indicated for improving luminal diameter for the treatment of de novo les	396 Bytes	2020-03-03	11	17	-
DevicePMAs@therightstef	P980035_S013	Approval for the medtronic at500 dddrp pacing system (model at501) and model 9968 software. The medtronic at500 dddrp pacing system is indicated for the following: 1) rate adaptive pacing in patient	1.65 KB	2020-03-03	11	68	-