PMA_Manual

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P910007_S013	Approval of the new method comparisons between the imx total psa assay and the imx psa assay. The c	788 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P920032_S008	Approval for the micro-pace model 4580. The device is indicated for "any clinical situation in whi	807 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P920032_S007	Approval for the model 4170 bedside single chamber, external pulse generator. The model 4170 is ind	566 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P180036_S000	Approval for the OPTIMIZER Smart System. The device which delivers Cardiac Contractility Modulation	469 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P160013_S000	Approval for the OCS Lung System, indicated for the preservation of standard criteria donor lungs in	184 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P160013_S002	Approval for the Organ Care System (OCS) Lung System. The TransMedics Organ Care System (OCS) Lung i	490 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P180037_S000	Approval for the Venovo Venous Stent System. The device is indicated for the treatment of symptomat	142 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P150028_S000	Approval for the Cheatham Platinum (CP) Stent System, including the CP Stent, Mounted CP Stent, Cove	1.07 KB	2020-03-03	13	-
DevicePMAs@therightstef	P150028_S001	Approval for the Covered CP Stent and Covered Mounted CP Stent Models. This device is indicated for	510 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P150046_S000	Approval for the Nevisense. This device is indicated for use on cutaneous lesions with one or more	1.1 KB	2020-03-03	13	-