age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P010031_S019	Approval for the models 2490g and 2490j carelink monitors and model 2491 ddma software for use with the insync sentry model 7297, insync ii protect model 7295, insync maximo model 7303, onyx vr model	473 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P810046_S203	Approval for the rx chassis 1(tm) coronary dilatation catheter. The device, as modified, is indicated for a) balloon dilatation of the stenotic portion of a coronary artery of bypass graft stenosis	412 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P100023_S053	Approval for removal of the ball from the tip of the corewire which islocated between the inner and outer lumen of the stent delivery system. the device, as modified, will be marketed under the trade	757 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P980035_S014	Approval for the medtronic kappa 900/800 pacemaker series models k(dr) 901, k(dr) 903, k(dr) 906, k(dr) 921, k(dr) 931, k(dr) 933, k(dr) 801, k(dr) 803, k(dr) 806, k(d) 901, k(d) 903, k(d) 906, kvdd90	1.94 KB	2020-03-03	11	-
DevicePMAs@therightstef	P940015_S011	Approval for the replacement of the dilution statement from the ?precaution? section and is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who failed to respond ade	296 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P920030_S002	Approval for the addition of a new indication for use. The device, as modified, will be marketed under the trade names ACS: 180 PSA2 assay and ACS: Centaur PSA2 assay and is indicated for the followi	485 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P890003_S054	Approval for the Medtronic "The Analyzer" Lead Analysis dEvice Model 8090 including the Model 5436 Analyzer Patient Cable, the Models 5103 and 5104 Analyzer Adaptors, and the Model 8190 Version 1.1 So	694 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P970007_S000	Approval for the IMx(R) Tacrolimus II Assay. This device is indicated for use as an in-vitro reagent sytemf or the quantitative determination of tacrolimus and some metabolites in human whole blood a	284 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P100042_S004	Approval for a post approval study labeling update. the device, as modified, will be marketed under the trade name aptima hpv assay. the aptima hpv assay is an in vitro nucleic acid amplification test	1.48 KB	2020-03-03	13	-
DevicePMAs@therightstef	P090013_S124	Approval for software changes to the mycarelink patient monitor m2.5 model 24950 with model 24955 rf head which supports the devices and medtronics reveal insertable cardiac monitors models 9529, 9528	349 Bytes	2020-03-03	11	-