age_PMA_annotations

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P890025_S010	Approval for change in monoclonal antibody manufacturing site from Sandoz Pharmaceuticals AG., Switzerland to Abbott Laboratories, Abbott Park, IL USA, under the trade name TDx(R)/TDxFLx(R) Cyclospori	376 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P970035_S014	Approval for the Medtronic AVE (AVE) S670 with Discrete Technology(TM) Over-The Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomiat	448 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P010031_S005	Approval for the insync ii marquis model 7289 with model 9989 application software. The system as modified, will be marketed under the trade name insync ii marquis and is indicated for ventricular an	711 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P120009_S000	Approval for the nit-occlud pda. this device is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimuman	235 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P950029_S016	Approval for the addition of the autosensing feature. The device, as modified, will be marketed under the trade name talent ii, models dr233 and sr133, and is indicated for rate adaptive pacing in pa	1.26 KB	2020-03-03	11	-
DevicePMAs@therightstef	P040034_S013	Approval to identify alternate applicators for use with the device. The device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.	192 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P990004_S004	Approval for marketing a powdered form of the absorbable gelatin sponge. The device, as modified, will be marketed under the trade name surgifoam absorbable gelatin powder (made from absorbable gelat	354 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P040014_S000	Approval for the ibi therapy cardiac ablation system. The device is indicated for mapping and for use with a compatible rf generator for: interruption of accessory atrioventricular (av) conduction pa	418 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P100044_S000	Approval for the propel sinus implant. This device is indicated for use in patients >= 18 years of age following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operativ	430 Bytes	2020-03-03	13	-
DevicePMAs@therightstef	P030027_S002	Approval for the addition of an intermediate ceramic liner size (36/48g); three replacement 36mm od ceramic heads with consistent offset (-3.5 mm, 0 mm, and +3.5 mm); and femoral stems and acetabular	690 Bytes	2020-03-03	11	-