PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P170008_S019	Approval for the expansion of the EluNIR Ridaforolimus Eluting Coronary Stent System product matrix by adding stent length of 38 mm in diameters 2.75, 3.0, 3.5 and 4.0 mm. This device is indicated for	392 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P030025_S000	Approval for the taxus express2 paclitaxel-eluting coronary stent system (monorail and over-the-wire). The device is indicated for improving luminal diameter for the treatment of de novo lesions <28	274 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P060008_S011	Approval to expand the product matrix to include the 38 mm length taxus libert paclitaxel-eluting coronary stent system. The device size will be marketed under the trade name taxus libert long paclit	459 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P170030_S000	Approval of the Orsiro Sirolimus Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic h	463 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P070015_S000	Approval for the xience v everolimus eluting coronary stent system, which will also be distributed as the promus everolimus eluting coronary stent system. this device is indicated for improving corona	380 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P020026_S026	Approval for the 4.0mm cypher sirolimus-eluting coronary stent on raptorrail (rx) delivery system. The device, as modified will be marketed under the trade name 4.00mm cypher sirolimus-eluting corona	495 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P070015_S122	Approval for the expansion of the indications for use of the xience v and xience nano everolimus eluting coronary stent system xience prime and xience prime ll everolimus eluting coronary stent system	1.31 KB	2020-03-03	11	-
DevicePMAs@therightstef	P110019_S070	Approval to change the distal balloon shaft, distal outer member and proximal hypotube components for the xience xpedition everolimus eluting coronary stent system. you indicated that upon implementat	332 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110010_S096	Approval for the promus element plus and promus premier everolimus-eluting platinum chromiumcoronary stent systems (monorail and over-the-wire). these devices are indicated forimproving luminal diamet	430 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P150003_S000	Approval for the synergy everolimus-eluting platinum chromium coronary stent system. this device is indicated for improving luminal diameter in patients with symptomatic heart disease, stableangina, u	388 Bytes	2020-03-03	11	-