PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P160043_S012	Approval for the Resolute Onyx Zotarolimus-Eluting Coronary Stent System. The device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with sy	488 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P060008_S053	Approval for: 1) a change of the supplier of toluene; and 2) a change to the incoming toluene specifications. The device is indicated for improving luminal diameter for the treatment of de novo lesio	286 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P100023_S015	Approval to expand the labeled indications for the ion paclitaxel-eluting coronary stent system (monorail and over-the-wire). The ion stent system is indicated for improving luminal diameter: 1) for	603 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P060008_S046	Approval to expand the labeled indications for the taxus libert paclitaxel-eluting coronary stent system. The taxus libert paclitaxel-eluting coronary stent system (monorail and over-the-wire systems	787 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P170008_S000	Approval for the EluNIR Ridaforolimus Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions	290 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110019_S000	Approval for the xience prime and xience prime ll everolimus eluting coronary stent system. this device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease	324 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P030025_S086	Approval to expand the labeled indications for the taxus express2 paclitaxel-eluting coronary stent system. The taxus express2 paclitaxel-eluting coronary stent system is indicated for improving lumi	724 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110019_S075	Approval for the xience v and xience nano everolimus eluting coronary stent system, xience prime and xience prime ll everolimus eluting coronary stent system, xience xpedition, xience xpedition sv and	1.89 KB	2020-03-03	11	-
DevicePMAs@therightstef	P020026_S017	Approval for the 2.25 mm cypher stent on raptorrail rx stent delivery system. The device, as modified, will be marketed under the trade name cypher and is indicated for improving coronary luminal dia	387 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110010_S001	Approval for the promus element plus everolimus-eluting platinum chromium coronary stent system (monorail and over-the-wire). this device is indicated for improving luminal diameter in patients with s	370 Bytes	2020-03-03	11	-