PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P790027_S069	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	P080021_S000	Approval for the xact foldable hydrophobic acrylic ultraviolet light-absorbing posterior chamber intraocular lens (iol). model x-60 and model x-70. this device is indicated for primary implantation fo	402 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	P990080_S004	Approval to revise the package insert with claims regarding reduction in postoperative spherical aberrations compared to lenses with spherical optics and improved night driving simulator performance.	487 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P850059_S024	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	P840060_S028	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	P930014_S015	Approval for the acrysof toric posterior chamber intraocular lens models sa60t3, sa60t4 and sa60t5. The devices are indicated for primary implantation in the capsular bag of the eye for visual correc	490 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P930014_S045	Approval for the acrysof toric posterior chamber intraocular lens models sn60t6, sn60t7, sn60t8, and sn60t9 and acrysof iq toric posterior chamber intraocular lens models sn6at6, sn6at7, sn6at8 and sn	595 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P810032_S050	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	P930014_S016	Approval for iol models sn60t3, sn60t4 and sn60t5. The device, as modified, will be marketed under the trade name acrysof toric single-piece natural iol and is indicated for primary implantation in t	449 Bytes	2020-03-03	11	0	-