consensus_PMA_Age_Indications

Documents (2,248) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P050007_S001	Approval for the starclose vascular closure system. This device is indicated as follows: the starclose vascular closure system is indicated for the percutaneous closure of common femoral artery acces	678 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P880090_S018	Approval to modify the directions for use for all legally marketed iols under the referenced pmas, to indicate the iols for use in adult patients. Previously, the iols were indicated for use in perso	484 Bytes	2020-03-03	11	6	-
DevicePMAs@therightstef	P110004_S001	Approval for modifications to the stent delivery system. the device, as modified, will be marketed under the trade name nirxcell cocr coronary stent on rx system and is indicated for improving coronar	407 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P030017_S230	Approval for a new lead anchor configuration. the device, as modified, will be marketed under the trade name clik x anchor and is indicated for use as an anchor for spinal cord stimulator leads.	194 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P970008_S026	Approval for a longer version of the cooled thermocath microwave delivery catheter. The longer antenna is 37 mm compared to the 28 mm antenna in the currently approved cooled thermocath catheter. Th	362 Bytes	2020-03-03	13	0	-
DevicePMAs@therightstef	P910062_S001	The device, as modified, will be marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyp	327 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P050007_S009	Approval for modifications to the indications for use. The device, as modified, will be indicated for the following: the percutaneous closure of common femoral artery access sites while reducing tim	902 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P040044_S011	Approval for minor design changes to the 6f/7f mynx vascular closure device. The device, as modified, will be marketed under the trade name m5 mynx vascular closure device and is indicated for use to	403 Bytes	2020-03-03	13	0	-
DevicePMAs@therightstef	P040018_S000	Approval for the advia centaur hav igm. Hav igm readypack reagents: this device is indicated for use for the advia centaur hav igm assay and is an in vitro diagnostic immunoassay for the qualitative	793 Bytes	2020-03-03	13	0	-
DevicePMAs@therightstef	P820060_S011	Approval for the addition of a system performed automated dilution protocol for a 1:101 sample dilution of amniotic fluid and is indicated for the quantitative determination of alpha-fetoprotein (afp)	581 Bytes	2020-03-03	13	0	-