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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameIMPLANTABLE MINIATURE TELESCOPE (IMT)
Classification Nametelescope, implantable, miniature
ApplicantVISION CARE OPHTHALMIC TECHNOLOGIES, LTD.
PMA NumberP050034
Date Received09/09/2005
Decision Date07/01/2010
Product Code
NCJ[ Registered Establishments with NCJ ]
Docket Number 10M-0361
Notice Date 07/07/2010
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the imt models wide angle 2. 2x and wide angle 2. 7x. This device is indicated for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe 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, as determined 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 low vision specialists (optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision; 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; and 6) agree to participate in postoperative visual training with a low vision specialist.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 
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