PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P120016_S000	Approval for the vascade vascular closure system (vcs). this device is indicated for femoral arterial access site closure while reducing times to hemostasis and ambulation in patients who haveundergon	476 Bytes	2020-03-03	11	13	-
DevicePMAs@therightstef	P930039_S003	Approval for distribution by viatron, inc. of the models capsure(r) z, 5033, 5034, 5534 and capsurefix(r) 4068 under a new trade name. The devices will be marketed under the trade names vitatron(r) i	367 Bytes	2020-03-03	11	4	-
DevicePMAs@therightstef	P100009_S000	Approval for the mitraclip clip delivery system (mitraclip cds). this device is indicated for the percutaneous reduction ofsignificant symptomatic mitral regurgitation (mr >= 3+) due to primary abnorm	596 Bytes	2020-03-03	13	25	-
DevicePMAs@therightstef	P100041_S000	Approval for the sapien transcatheter heart valve, model 9000tfx, sizes 23mm and 26mm and accessories. This device is indicated for transfemoral delivery in patients with severe symptomatic native ao	431 Bytes	2020-03-03	11	22	-
DevicePMAs@therightstef	P990055_S008	Approval of the acs: 180 and the centaur complexed psa (cpsa) assays on the advia centaur cp system. The device, as modified, will be marketed under the trade name advia centaur cp cpsa and is indica	729 Bytes	2020-03-03	13	23	-
DevicePMAs@therightstef	P120005_S036	Approval for software modifications to the existing firmware update tool to allow the tool to be run on mac os x operating systems, to improve the runtime and simplify installation steps on currently	1.15 KB	2020-03-03	11	38	-
DevicePMAs@therightstef	P060008_S008	Approval to expand the product matrix to include the 2.25 mm taxusliberte paclitaxel-eluting coronary stent system. this device size will be marketed under thetrade name taxus liberte atom paclitaxel-	455 Bytes	2020-03-03	11	21	-
DevicePMAs@therightstef	P050033_S005	Approval for the change in product trade name. The device, as modified, will be marketed under the trade name elevess and is indicated for injection into the mid to deep dermis for the correction of	272 Bytes	2020-03-03	11	11	-
DevicePMAs@therightstef	P000014_S000	Approval for the vitros immunodiagnostic products anti-hbs reagent pack and calibrators. The device is indicated for: the qualitative in vitro determination of total antibody to hepatitis b surface	772 Bytes	2020-03-03	11	33	-
DevicePMAs@therightstef	P970015_S031	Approval for the post approval study. The device remains indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from l2-s1. Ddd is def	553 Bytes	2020-03-03	13	34	-