IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

FDA premarket approval P050034/S013 · decided 2014-10-08

Approval details

PMA number

P050034

Supplement

S013

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Generic name

Telescope, implantable, miniature

Applicant

Samsara Vision, Inc.

Date received

2013-12-26

Decision date

2014-10-08

Days to decision

286 days

Decision code

APPR

Product code

NCJ

Advisory committee

Ophthalmic

Expedited review

No

Location

Far Hills, NJ

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 CORNE