PMA_age_indications

Documents (2,236) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P080004_S007	Approval for packaging changes to the model py-60ad. The device, as modified, will be marketed under the trade name isert model py-60adc and is indicated for primary implantation in the capsular bag	310 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P880091_S010	Approval for lens model aa-4207vf. The device is to be placed in the capsular bag of the eye and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age	315 Bytes	2020-03-03	11	4	-
DevicePMAs@therightstef	P980040_S065	Approval for the Tecnis Symfony Extended Range of Vision Intraocular Lens. The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correctio	1.3 KB	2020-03-03	11	0	-
DevicePMAs@therightstef	P990013_S014	Approval for parametric lot release using existing validated steam sterilization cycles. The device, as modified, will be marketed under the trade name collamer ultraviolet-absorbing posterior chambe	546 Bytes	2020-03-03	11	4	-
DevicePMAs@therightstef	P870073_S017	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	P090022_S022	Approval to reduce the size of the secondary packaging which houses the pouched intraocular lenses, label and directions for use (dfu). the device, as modified, will be marketed under the trade name s	376 Bytes	2020-03-03	11	3	-
DevicePMAs@therightstef	P060022_S000	Approval for the akreos posterior chamber intraocular lens (iol), model: akreos advanced optics aspheric lens, ao60. The device is indicated for primary implantation for the visual correction of apha	344 Bytes	2020-03-03	11	0	-
DevicePMAs@therightstef	P010027_S000	Approval for the allergan, inc. model ac21b ultraviolet-absorbing pmma anterior chamber intraocular lens, available in three overall diameters (12.0 mm, 13.0 mm, 14.0 mm). The application is a licens	1.03 KB	2020-03-03	11	4	-
DevicePMAs@therightstef	P990080_S002	Approval for a new trade name for the model z9000 foldable posterior chamber intraocular lens, and other lens models which incorporate the modified prolate anterior optic surface. The device, as modi	522 Bytes	2020-03-03	11	4	-
DevicePMAs@therightstef	P970034_S009	Approval for ophthalmic innovations international, inc. to private-label its pma-approved posterior-chamber intraocular lenses for distribution in the united states by ciba vision corporation. The de	514 Bytes	2020-03-03	11	4	-