PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	updated_at
DevicePMAs@therightstef	P110010_S028	Approval for removal of the ball from the tip of the corewire which is located between the inner and outer lumen of the stent delivery system. the device, as modified, will be marketed under the trade	759 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P160043_S001	Approval for the Resolute Onyx Zotarolimus-Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with s	356 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110010_S000	Approval for the promus element plus everolimus-eluting platinum chromium coronary stent system. this device is indicated for improving luminal diameter in patients with symptomatic heart disease due	310 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P070015_S054	Approval to expand the product matrix to include the 2.25 mm xience v everolimus eluting coronary stem system. this device size will be marketed under the trade name xience nano everolimus eluting co	817 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P110013_S005	Approval for the resolute integrity zotarolimus-eluting coronary stent system. this device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, wi	361 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P150003_S003	Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire). This device is indicated for improving luminal diameter in patients, including those	461 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	P110010_S090	Approval for changes to the accessory kit (removal of clipit hypotube clips, substitution of flushing needle manufactured by new vendor, modification of carrier tube clip and update to the edfu) and i	431 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P060033_S000	Approval for the endeavor zotarolimus-eluting coronary stent on the over-the-wire (otw), rapid exchange (rx), or multi-exchange ii (mx2) stent delivery systems. The device is indicated for improving	394 Bytes	2020-03-03	11	-
DevicePMAs@therightstef	P030025_S028	Approval for the taxus express2 paclitaxel-eluting coronary stent system in-stent restenosis (isr) indication. The device is indicated for improving luminal diameter for the treatment of de novo les	396 Bytes	2020-03-03	11	-