PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P100016_S001	Approval for a change to the trade name of the approved lenses and labeling changes to the unit carton, including a change to the color scheme and format. the device, as modified, will be marketed und	479 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P980040_S000	Approval for the AMO SENSAR Soft Acrylic, UV Light-Absorbing, Posterior Chamber Intraocular Lens (IOL), Model AR40. This device is indicated for the visual correction of aphakia in persons 60 years o	352 Bytes	2020-03-03	11	4	-
DevicePMAs@therightstef	P810055_S068	Approval to extend the dioptric power range of Model 812B to -10D to +40D. The device is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoin	323 Bytes	2020-03-03	11	4	-
DevicePMAs@therightstef	P930014_S014	Approval to modify the indications statement, to indicate the iols for use in adult patients following cataract surgery. Previously, the iols were indicated for use in persons 60 years of age or olde	464 Bytes	2020-03-03	11	6	-
DevicePMAs@therightstef	P910056_S010	Approval for a material change and design modifications (3-piece to 1-piece design and aspheric surface) to the approved bausch & lomb silicone lens c31ub. The device, as modified, will be marketed u	442 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P860002_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	P990014_S004	Approval for a new trade name for the hp60m hydrogel iol. The device, as modified, will be marketed under the trade name "meridian" and is indicated for primary implantation for the visual correction	431 Bytes	2020-03-03	11	4	-
DevicePMAs@therightstef	P870013_S016	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	P060011_S000	Approval for the c-flex model 570c intraocular lens (iol). The device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed	279 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P840039_S051	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	-