IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Premarket Approval P050034

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the imt models wide angle 2. 2x and wide angle 2. 7x. This device is indicated for monocularimplantation to improve vision in patients greater than or equal to 75 years of age with stablesevere to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas associated with end-stage age-related macular degeneration. Patients must:1) have retinal findings of geographic atrophy or disciform scar with foveal involvement, asdetermined by fluorescein angiography;2) have evidence of visually significant cataract (> grade 2);3) agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with lowvision specialists (optometrist or occupational therapist) in the use of an externaltelescope sufficient for patient assessment and for the patient to make an informeddecision;4) achieve at least a 5-letter improvement on the etdrs chart with an external telescope;5) have adequate peripheral vision in the eye not scheduled for surgery; and6) agree to participate in postoperative visual training with a low vision specialist.

• Device: IMPLANTABLE MINIATURE TELESCOPE (IMT)
• Classification Name: Telescope, Implantable, Miniature
• Generic Name: Telescope, Implantable, Miniature
• Applicant: VISIONCARE, INC.
• Date Received: 2005-09-09
• Decision Date: 2010-07-01
• Notice Date: 2010-07-07
• PMA: P050034
• Supplement: S
• Product Code: NCJ
• Docket Number: 10M-0361
• Advisory Committee: Ophthalmic
• Expedited Review: Yes
• Combination Product: No
• Applicant Address: VISIONCARE, INC. 14395 Saratoga Avenue #150 saratoga, CA 95070
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P050034		Original Filing
S020	2018-09-11	Normal 180 Day Track No User Fee
S019	2017-09-21	30-day Notice
S018
S017	2016-09-26	30-day Notice
S016	2016-09-23	Real-time Process
S015	2014-11-28	Normal 180 Day Track No User Fee
S014	2014-06-11	Real-time Process
S013	2013-12-26	Normal 180 Day Track
S012	2013-12-12	30-day Notice
S011	2013-08-08	30-day Notice
S010	2013-07-16	30-day Notice
S009	2013-05-15	Normal 180 Day Track No User Fee
S008	2012-12-20	30-day Notice
S007	2012-12-04	30-day Notice
S006	2011-12-27	Real-time Process
S005	2011-03-02	30-day Notice
S004	2010-12-15	Real-time Process
S003	2010-09-29	30-day Notice
S002	2010-08-30	Normal 180 Day Track No User Fee
S001	2010-08-30	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
M687PR00020000	P050034	012
M687PR00018000	P050034	012