Approval to modify the indications for use for the imt to include patients 65 to 74 years of age from the current minimum of 75 years, to revise the professional and patient labeling to update the data based on the results out to 8-years post imt implantation, and to revise the acceptance of risk and informed decision agreement, as well as the professional and patient labeling, to emphasize that the longer the imt is in the eye, the greater the potential risk of developing vision-impairing corneal edema which may lead to the need for corneal transplant and possible telescope removal. The device, as modified, will be marketed under the trade name implantable miniature telescopetm (by dr. Isaac lipshitz) (imt) models wide angle 2. 2x and wide angle 2. 7x and is indicated for monocular implantation to improve vision in patients greater than or equal to 65 years of age with stable severe to profound vision impairment (best corrected distance visualacuity 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.
| Device | IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X |
| Classification Name | Telescope, Implantable, Miniature |
| Generic Name | Telescope, Implantable, Miniature |
| Applicant | VISIONCARE, INC. |
| Date Received | 2013-12-26 |
| Decision Date | 2014-10-08 |
| PMA | P050034 |
| Supplement | S013 |
| Product Code | NCJ |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VISIONCARE, INC. 14395 Saratoga Avenue #150 saratoga, CA 95070 |
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