PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P980049_S010	Approval for modifications to the programming head of the orchestra programmer, including the addition of high-speed telemetry and other changes. The device, as modified, will be marketed under the t	382 Bytes	2020-03-03	11	8	-
DevicePMAs@therightstef	P000009_S000	Approval for the phylax av icd system including the pulse generator, model number 122 382 and phylax av software cartridge swm 1000/i-gav. 2.u, model number 128 814. The device is indicated for use i	719 Bytes	2020-03-03	11	38	-
DevicePMAs@therightstef	P940015_S000	Approval for synvisc(r) hylan g-f 20. This device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharma	263 Bytes	2020-03-03	13	7	-
DevicePMAs@therightstef	P060027_S015	Approval for the paradym vr model 8250 and dr model 8550 with smartview 2.18ug1 programmer software and the paradym crt-d model 8750 with hardware andmanufacturing changes and labeling and programmer	774 Bytes	2020-03-03	11	27	-
DevicePMAs@therightstef	P060031_S003	Approval for use on the evolis automated microplate system. The device, as modified, will be marketed under the trade name bio-rad monolisa anti-hbc eia and is indicated for: the monolisa anti-hbc e	773 Bytes	2020-03-03	11	39	-
DevicePMAs@therightstef	P890003_S000	Approval for the Synergyst II Models 7070 and 7071 Pulse Generators and the Model 9710 Programmer with the Model 9739A MemoryMod. This device is indicated for cardiac pacing.	175 Bytes	2020-03-03	11	6	-
DevicePMAs@therightstef	P010015_S016	Approval for modifications to the device labeling to describe the care-hf clinical study. medtronic also requests a reformatting of the indications statement and the addition of a clinical outcomes se	904 Bytes	2020-03-03	11	35	-
DevicePMAs@therightstef	P040037_S000	Approval for the gore viabahn endoprosthesis. The device is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with refe	250 Bytes	2020-03-03	11	11	-
DevicePMAs@therightstef	P090022_S004	Approval to extend the power range for which lenses are marketed in 1/4 diopter increment from 18.0 through 25.0 diopters to 15.0 through 25.0 diopters. The device, as modified, will be marketed unde	467 Bytes	2020-03-03	11	16	-
DevicePMAs@therightstef	P130009_S034	Approval for the sapien xt transcatheter heart valve, model 9300tfx, and accessories. this device is indicated for use in patients with symptomatic heart disease due to either severe native calcific a	527 Bytes	2020-03-03	11	28	-