PMA_Manual

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P840001_S219	Approval for of the medtronic surescantm mri implantable neurostimulation system, which consists of	1.65 KB	2020-03-03	11	29	-
DevicePMAs@therightstef	P040004_S010	Approval for claims to test neonate and pediatric populations with the fda approved advia centaur hb	1.9 KB	2020-03-03	11	20	-
DevicePMAs@therightstef	P980016_S668	Approval for an update to the indications for use to include pacing at the bundle of His. The device	459 Bytes	2020-03-03	10	14	-
DevicePMAs@therightstef	P170037_S000	Approval for the Sangia Total PSA Test. The Sangia Total PSA Test is an immunoassay indicated to qu	513 Bytes	2020-03-03	13	12	-
DevicePMAs@therightstef	P120014_S000	Approval for the thxid braf kit for use on the abi 7500 fast dx real-time pcr instrument. this devic	705 Bytes	2020-03-03	13	12	-
DevicePMAs@therightstef	P000020_S004	Approval for the addition of another ablation catheter model to the existing stinger(tm) product lin	391 Bytes	2020-03-03	11	9	-
DevicePMAs@therightstef	P120019_S019	Approval for the cobas EGFR Mutation Test v2. The device is a real-time PCR test for the qualitativ	2.41 KB	2020-03-03	13	8	-
DevicePMAs@therightstef	P100031_S000	Approval for the elecsys anti-hbc immunoassay & elecsys precicontrol anti-hbc for use on the modular	1006 Bytes	2020-03-03	11	7	-
DevicePMAs@therightstef	P010032_S092	Approval for the st. jude medical invisible trial system comprising of the following devices: 1) st.	952 Bytes	2020-03-03	11	7	-
DevicePMAs@therightstef	P160052_S000	Approval for the PartoSure test. The device is a rapid, qualitative test for detecting the presence	564 Bytes	2020-03-03	13	7	-