blah6_medical_device

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P860019_S144	Approval for the SCIMED(R) MAXXUM(TM) PTCA Catheter. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving	221 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	N50510_S138	Approval for the addition of the antibiotic vancomycin at concentrations of 0.5 and 1 ug/ml to the vitek(r) 2 s. pneumoniae susceptibility test system. The device, as modified, will be marketed under	439 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P050050_S000	Approval for the star ankle. The device is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthrit	203 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P110007_S000	Approval for the healon endocoat ovd. healon endocoat ovd is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior	822 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P010052_S000	Approval for the immulite anti-hbs and immulite 2000 anti-hbs. The devices are indicated for: immulite anti-hbs: for in vitro diagnostic use with the immulite automated immunoassay analyzer for the	1.78 KB	2020-03-03	11	-
DevicePMAs@therightstef	P160034_S000	Approval for the Powerheart AED G3 Pro. The Powerheart AED G3 Pro is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are: 1) unresponsive; 2) not breath	570 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P100027_S000	Approval for the inform her2 dual ish dna probe cocktail. this device is indicated for: the inform her2 dual ish dna probe cocktail is intended for use in determining her2 gene status by enumeration o	916 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P160002_S009	Approval for VENTANA PD L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD L1 clone SP142. The device is intended for use in the assessment of the programmed	1.65 KB	2020-03-03	13	-
DevicePMAs@therightstef	P970042_S002	Approval for 1) the use of two generic ursodiols, one manufactured by amide pharmaceutical and one by teva pharmaceutical, in addition to actigall; 2) a change in the post-approval study's medical m	1.08 KB	2020-03-03	13	-
DevicePMAs@therightstef	P040006_S000	Approval for the charite artificial disc. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (ddd) at one level from l4-s1. Ddd is defined a	568 Bytes	2020-03-03	13	-