PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P150003_S003	Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire). This device is indicated for improving luminal diameter in patients, including those	461 Bytes	2020-03-03	11	20	-
DevicePMAs@therightstef	P850007_S024	Approval t use a smaller gauge wire for the Transducer Coil, change from PVC to Neoprene for the inside and outside covers of both front and rear transducer coils, and slightly reduce the thickness of	511 Bytes	2020-03-03	13	20	-
DevicePMAs@therightstef	N50510_S090	Approval for the addition of the antibiotic tobramycin to the Vitek(R) 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek(R) 2 and is ind	371 Bytes	2020-03-03	13	18	-
DevicePMAs@therightstef	P950037_S024	Approval for the solox vdd pacing lead. The device, as modified, will be marketed under the trade name solox vdd pacing lead and is indicated as follows: the solox lead is indicated for use as part	1.4 KB	2020-03-03	13	50	-
DevicePMAs@therightstef	P990052_S000	Approval for the vibrant soundbridge system. This device is indicated for providing a useful level of sound perception to individuals via mechanical stimulatino of the ossicles. The vibrant soundbri	493 Bytes	2020-03-03	13	23	-
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	P960058_S043	Approval for process control improvements to the hires90k coil-case/electrode subassembly final molding process. The proposed changes include an external thermocouple to provide closed-loop control o	699 Bytes	2020-03-03	11	28	-
DevicePMAs@therightstef	P960009_S051	Approval for the following new components and accessories for the activa rcrechargeable implantable neurostimulation system: activa rc, model 37612 (neurostimulator) patient programmer, model 37642 mo	1.28 KB	2020-03-03	11	41	-
DevicePMAs@therightstef	P160001_S018	Approval for the Obalon Balloon System. The device is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 to 40 kg/m2) wh	441 Bytes	2020-03-03	13	21	-
DevicePMAs@therightstef	P120019_S007	Approval for the cobas egfr mutation test v2. this device is indicated for: the cobas egfr mutation test v2 is a real-time pcr test for the qualitative detection of defined mutations of the epidermal	1.08 KB	2020-03-03	13	47	-