PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P880086_S114	Approval for modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the	1.6 KB	2020-03-03	11	-
DevicePMAs@therightstef	P950037_S079	Approval for a stand-alone version of the pacing system analyzer function found in the ics 3000 implant control system. The device, as modified, will be marketed under the trade name reliaty by biotr	360 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P950037_S046	Approval for the lumax implantable cardioverter defibrillators (icds), models 300 vr, 340 vr, 300 vr-t, 340 vr-t, 300 dr, 340 dr, 300 dr-t, 340 dr-t, 300 hf, 340 hf, 300 hf-t and 340 hf-t and programm	628 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P890003_S329	Approval of the evera mri xt/s dr and vr implantable cardioverterdefibrillator devices and programmer application software model sw033 as well as extension of mr conditional labeling and use for sprin	825 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P910023_S088	Approval for modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the	1.6 KB	2020-03-03	11	-
DevicePMAs@therightstef	P980035_S277	Approval of an mr-conditional system permitting implanted patients to undergo mri scans provided specified conditions are met. The devices, as modified, make up the advisa dr mri surescan system and	1.67 KB	2020-03-03	11	-
DevicePMAs@therightstef	P950037_S092	Approval for the ics 3000 programmer application software version psw 1004.u, and the estella dr; estella dr-t; estella sr; estella sr-t; ecuro dr; ecuro dr-t; ecuro sr; ecuro sr-t; effecta d; effecta	363 Bytes	2020-03-03	11	-
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	-
DevicePMAs@therightstef	P890003_S299	Approval for software changes to the mycarelink patient monitor m2.5 model 24950 with model 24955 rf head which supports the devices and medtronics reveal insertable cardiac monitors models 9529, 9528	349 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P890003_S309	Approval for the viva/brava quadripolar cardiac resynchronization therapy defibrillator (crt-d) devices and is indicated for patients who require ventricular antitachycardia pacing and ventricular def	619 Bytes	2020-03-03	11	-