age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P010015_S016	Approval for modifications to the device labeling to describe the care-hf clinical study. medtronic also requests a reformatting of the indications statement and the addition of a clinical outcomes se	904 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P960040_S053	Approval for the vitality he model t180 implantable cardioverter defibrillator (icd) system and the consult programmer software application model 2896 version 1.0. The device is indicated as follows:	373 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P960040_S025	Approval for vitality automatic implantable cardioverter defibrillator (aicd) systems (vitality dr model 1871, vitality vr model 1870 and vitality + dr model 1872), and model 2857 software, version 1.	791 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P090013_S281	Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and i	459 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P090013_S124	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	P090013_S200	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	P010012_S165	Approval for the teligen implantable cardioverter defibrillator models e102 and e110, the cognis cardiac resynchronization therapy defibrillator (crt-d) models n118 and n119, application software mode	1006 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P960040_S155	Approval for the teligen implantable cardioverter defibrillator models e102 and e110, the cognis cardiac resynchronization therapy defibrillator (crt-d) models n118 and n119, application software mode	1006 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P010012_S255	Approval for incepta, energen. punctua and teligen icd models and the incepta, energen. punctua and cognis crt-d models and prm software application model 2868 and pulse generator software. the device	854 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P960040_S036	Approval for changes to the indications for use and clinical study section labeling. The devices are indicated for: for icds (ventak prx, mini, vitality, ventak av and prizm): guidant icds are inten	1.24 KB	2020-03-03	9	-