age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P890057_S007	Approval for replacement flexible tubing and heated wire accessories and is indicated for use with mdoe 3100 and 3100a high frequency oscillatory ventilator.	157 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P030029_S000	Approval for the advia centaur anti-hbs readypack reagents and advia centaur anti-hbs readypack calibrators. The device is indicated for the qualitative determination of total antibodies to hepatitis	793 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P960009_S318	Approval for the Medtronic DBS Therapy for expanding the indications to include Epilepsy. Bilateral stimulation of the anterior nucleus of the thalamus (ANT) using the Medtronic DBS System for epilep	845 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P140021_S002	Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 602 analyzer. The d	1.32 KB	2020-03-03	13	-
DevicePMAs@therightstef	P110021_S026	Approval for removal of access approach from device labeling. the device is indicated for patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency an	694 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P910007_S009	Approval for the abbott imx total psa assay. The device, as modified, will be marketed under the trade name abbott imx total psa assay and is indicated as an aid in the detection of prostate cancer w	344 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P830045_S090	Approval to modify the header design of a currently marketed device. The device, as modified, will be marketed under the trade name verity adx xl vdr model 5456i and is indicated as follows: the ver	971 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P080020_S000	Approval for the gel-one. The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-ster	275 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P050038_S005	Approval for the addition of a new trade name. The device, as modified, will be marketed under the trade name hemostase mph and is indicated for use in surgical procedures (except neurological and op	399 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P990081_S002	Approval of labeling changes for the pathway her-2/neu (clone cd11) in the "intended use" section, addition of an "optional equipment not provided" section and changes to the "principles and procedure	1.67 KB	2020-03-03	13	-