age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P050017_S006	Approval for a product line extension that represents modifications to the 6fr version of the zilver vascular stent. in addition, approval of minor changes to the stent and delivery system and the ad	609 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P020050_S005	Approval for a change in the repetition rate from 200 hz to 400 hz. The device, as modified, will be marketed under the trade name allegretto wave eye-q excimer laser system and is indicated for lase	992 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P880086_S067	Approval is for the Model 3304 Programmer Software for use with the Model 3500 and 3510 Programmers. The device is indicated for programming and interrogation of implanted St. Jude pacemakers.	193 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P120005_S031	Approval for the dexcom g4 platinum (pediatric) continuous glucose monitoring system. this device is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2	851 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P960004_S014	Approval for the silicone and polyurethane thinline(tm) ii sterox and fineline(tm) ii steroid eluting pacing leads. The devices are indicated for chronic pacing and sensing of the ventricle and/or at	249 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P150029_S000	Approval for the iPro2 System. This device is indicated for: The iPro2 Recorder is to be used with either Enlite sensor or Sof-Sensor and is intended to continuously record interstitial glucose levels	1.09 KB	2020-03-03	11	-
DevicePMAs@therightstef	P960058_S000	Approval for the clarion multi-strategy cochlear implant. The device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation o	1.18 KB	2020-03-03	11	-
DevicePMAs@therightstef	P950037_S038	Approval for the addition of a drug collar to the pacing lead. The device, as modified, will be marketed under the trade name selox st/jt and is indicated as follows: selox st and selox jt steroid e	938 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P930039_S004	Approval for the SureFix(TM) Model 5072 Steroid-Eluting Screw-In Pacing Lead with a Non-Retractable Helix. The device, as modified, will be marketed under the trade name SureFix(TM) Model 5072 Pacing	419 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P180036_S000	Approval for the OPTIMIZER Smart System. The device which delivers Cardiac Contractility Modulation therapy, is indicated to improve 6-minute hall walk distance, quality of life, and functional statu	469 Bytes	2020-03-03	13	-