PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P910007_S004	Approval for the addition of a new intended use and is indicated for the quantitative measurement of Prostate Specific Antigen (PSA) in: 1) Human serum as an adjunctive test used as an aid in the mana	438 Bytes	2020-03-03	13	18	-
DevicePMAs@therightstef	P960009_S052	Approval for new activa pc implantable neurostimulation system (ins), intended for deep brain stimulation (dbs). the device, as modified, will be marketed under thetrade name activa pc and is indicate	946 Bytes	2020-03-03	11	30	-
DevicePMAs@therightstef	P140026_S000	Approval for the enroute transcarotid stent system. this device is indicated for use in conjunction with the enroute transcarotid neuroprotection system (nps) for the treatment of patients at high ris	780 Bytes	2020-03-03	13	35	-
DevicePMAs@therightstef	P040037_S060	Approval for the gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface. these devices are indicated for improving blood flow in patients with symptomatic periphera	616 Bytes	2020-03-03	11	23	-
DevicePMAs@therightstef	P990037_S000	Approval for the vascular solutions duett(tm) sealing device. This device is indicated for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have	340 Bytes	2020-03-03	11	9	-
DevicePMAs@therightstef	P990010_S001	The device, as modified, will be marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyp	327 Bytes	2020-03-03	11	6	-
DevicePMAs@therightstef	P850035_S023	Approval for the addition of a 4cm mesh cathode to be used with the SpF-2T stimulator and a 8cm mesh cathode to be used with the SpF-XL IIb stimulator. The device, as modified, will be marketed under	311 Bytes	2020-03-03	13	3	-
DevicePMAs@therightstef	P930012_S010	Approval for 1) a change in trade names for the Champion(TM) HP PTCA Catheters and Champion(TM) HP PTCA Catheters with Wrap(TM) Sheathing System previously approved under PMA supplements 5, 8, and 9,	594 Bytes	2020-03-03	11	17	-
DevicePMAs@therightstef	P120012_S000	Approval for the abbott realtime hcv genotype ii, abbott realtime hcv genotype ii control kit, and uracil-glycosylase(ung). this device is indicated for: abbott realtime hcv genotype iithe abbott rea	1.65 KB	2020-03-03	13	56	-
DevicePMAs@therightstef	P130017_S029	Approval to expand the indicated age range for Cologuard Stool DNA-Based Colorectal Cancer Screening Test from 50 years or older to 45 years or older.	150 Bytes	2020-03-03	13	8	-