Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
• Generic Name: Telescope, implantable, miniature
• Applicant: Samsara Vision Inc.; 27 US Highway 202; Suite 8/9; Far Hills, NJ 07931
• PMA Number: P050034
• Supplement Number: S013
• Date Received: 12/26/2013
• Decision Date: 10/08/2014
• Product Code: NCJ
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
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.