blah6_medical_device

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P830063_S006	Approval for modifications to the gambro prisma tpe 2000 set with plasmafilter pf 2000n to permit the use of the plasmafilter with the gambro prismaflex system. The device, as modified, will be marke	297 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P030040_S002	Approval for the transition of the advia centaur hbc igm assay to a new platform in the centaur family of instruments, the centaur cp. the device, as modified, will be marketed under the trade name ad	1.52 KB	2020-03-03	11	-
DevicePMAs@therightstef	P980003_S016	Approval for modification to the hardware, software, and new accessories of the ept-1000 series of cardiac ablation systems. The device, as modified, will be marketed under the trade name maestro 300	735 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110010_S028	Approval for removal of the ball from the tip of the corewire which is located between the inner and outer lumen of the stent delivery system. the device, as modified, will be marketed under the trade	759 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P010055_S007	Approval for modification of the indications for use and associated modifications to the catheter, antenna, and temperature probe for patients with prostates smaller than currently indicated. the devi	429 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P160012_S000	Approval for the LIFEPAK CR Plus Defibrillator, LIFEPAK EXPRESS Defibrillator, and CHARGE-PAK Battery Charger. The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are indicated for use on patient	1021 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P020014_S000	Approval for the essure system. The device is indicated for permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.	154 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P970005_S000	Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) i	624 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P990038_S000	Approval for the diasorin eti-mak-2 plus assay. The device is indicated for: eti-mak-2 plus is an in vitro enzyme immunoassay (eia) intended for use in the qualitative determination of hepatitis b su	807 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P830045_S064	Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Sof	294 Bytes	2020-03-03	13	-