FDA.reportPublic FDA data

PMA P050034S013

Device
IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
Applicant
Samsara Vision, Inc.
PMA number
P050034
Supplement
S013
Product code
NCJ
Decision date
2014-10-08
Classification
Telescope, Implantable, Miniature
Generic name
Telescope, implantable, miniature
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.

Current openFDA PMA Record#

Device
IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
Applicant
Samsara Vision, Inc.
PMA number
P050034
Supplement
S013
Product code
NCJ
Generic name
Telescope, implantable, miniature
Decision date
2014-10-08
Decision code
APPR
Date received
2013-12-26
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
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.