PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P970004_S004	Approval for the Medtronic(R) Interstim(R) System for Urinary Control. This device is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/	289 Bytes	2020-03-03	11	9	-
DevicePMAs@therightstef	P980015_S000	Approval for the Sharpx(TM) Needle Destruction Unit. The device is indicated for the destruction of 19 to 27 gauge hypodermic needles up to two inches in length. The unit is for use by healthcare pr	287 Bytes	2020-03-03	13	13	-
DevicePMAs@therightstef	P180036_S000	Approval for the OPTIMIZER Smart System. The device which delivers Cardiac Contractility Modulation therapy, is indicated to improve 6-minute hall walk distance, quality of life, and functional statu	469 Bytes	2020-03-03	13	22	-
DevicePMAs@therightstef	P010030_S011	Approval for the next generation of wearable defibrillators designed to be smaller, lighter, and more user-friendly. The device, as modified, will be marketed under the trade name lifevest wearable d	357 Bytes	2020-03-03	13	10	-
DevicePMAs@therightstef	P810046_S198	The device is indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; 2) balloon dilatation of a	329 Bytes	2020-03-03	11	18	-
DevicePMAs@therightstef	P890043_S035	Approval for the flexi-cut(tm) direction debulking system. The flexi-cut(tm) direction debulking system is indicated for use in coronary artery disease accessible to dca (directional coronary atherec	494 Bytes	2020-03-03	11	20	-
DevicePMAs@therightstef	P980006_S004	Approval for the pure vision (balafilcon a) visibility tinted contact lens. The device is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection o	773 Bytes	2020-03-03	11	18	-
DevicePMAs@therightstef	P920032_S007	Approval for the model 4170 bedside single chamber, external pulse generator. The model 4170 is indicated for "any clinical situation in which the use of temporary pacemaker on a patient provides the	566 Bytes	2020-03-03	13	29	-
DevicePMAs@therightstef	P910023_S069	Approval for modifications to the epic+ icds to include higher energy output, software modifications, and a different header type. The device, as modified, will be marketed under the trade name atlas	661 Bytes	2020-03-03	11	15	-
DevicePMAs@therightstef	P010054_S017	Approval for the extension of the elecsys anti-hbs test system onto the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade elecsys anti-hbs test system and is	1.19 KB	2020-03-03	11	45	-