PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P900061_S044	Approval for the general use indication for implantable cardioverter defibrillator models micro jewel 7221, micro jewel ii 7223, gem dr 7271, gem ii dr 7273 and gem ii vr 7229 and are indicated to pro	339 Bytes	2020-03-03	11	13	-
DevicePMAs@therightstef	P010068_S000	Approval for the navistar ds and celsius ds diagnostic/ablation catheters, stockert 70 generator and accessories. The navistar ds and celsius ds catheters and related accessory devices are indicated	536 Bytes	2020-03-03	11	19	-
DevicePMAs@therightstef	P030026_S016	Approval for revision of the intended use to include use of the vitros 5600integrated system and vitros 3600 immunodiagnostic system with the anti-hbc igm assay. The device, as modified, will be mark	1.59 KB	2020-03-03	11	71	-
DevicePMAs@therightstef	P150004_S023	Approval for Axium Neurostimulator System. The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid i	361 Bytes	2020-03-03	13	23	-
DevicePMAs@therightstef	P810002_S058	Approval for an additional configuration of the aortic valved graft using the sjm masters series aortic valved prosthesis with the vascutek gelweave valsalva graft. The device, as modified, will be m	446 Bytes	2020-03-03	13	14	-
DevicePMAs@therightstef	P890003_S054	Approval for the Medtronic "The Analyzer" Lead Analysis dEvice Model 8090 including the Model 5436 Analyzer Patient Cable, the Models 5103 and 5104 Analyzer Adaptors, and the Model 8190 Version 1.1 So	694 Bytes	2020-03-03	11	30	-
DevicePMAs@therightstef	P120014_S000	Approval for the thxid braf kit for use on the abi 7500 fast dx real-time pcr instrument. this device is indicated for: the thxid braf kit is an in vitro diagnostic device intended for the qualitative	705 Bytes	2020-03-03	13	22	-
DevicePMAs@therightstef	P870015_S030	Approval for a transportable configuration of the Medstone STS lithotripter. The devices, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated	334 Bytes	2020-03-03	13	9	-
DevicePMAs@therightstef	P020035_S000	Approval for the x-press 6 french vascular closure system. The device is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have under	638 Bytes	2020-03-03	11	29	-
DevicePMAs@therightstef	P930016_S003	Approval for the visx excimer laser system (models b & c). This device is indicated for myopic astigmatic photorefractive keratectomy (prka) using an ablation zone with a 6.0 mm major axis	189 Bytes	2020-03-03	11	7	-