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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/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.
 
DeviceIMPLANTABLE MINIATURE TELESCOPE (IMT)
Generic NameTelescope, implantable, miniature
ApplicantSamsara Vision Inc.
27 US Highway 202
Suite 8/9
Far Hills, NJ 07931
PMA NumberP050034
Date Received09/09/2005
Decision Date07/01/2010
Product Code NCJ 
Docket Number 10M-0361
Notice Date 07/07/2010
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S019 S020 
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