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Implantable Miniature Telescope

by Samsara Vision, Inc.

PMA P050034

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P050034↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP050034 Date1 Jul 2010ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Implantable Miniature Telescope (Imt)
Generic Name
Telescope, implantable, miniature
PMA Number
FDA Product Code
NCJ
Device Class
Class III
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Implantable Miniature Telescope (IMT) is an ophthalmic device indicated for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe to profound vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration. It is approved for the IMT models Wide Angle 2.2X and Wide Angle 2.7X.

The device is supplied as an implantable miniature telescope and requires pre-surgery training and assessment with low-vision specialists, followed by postoperative visual training. Patients must meet specific criteria including retinal findings of geographic atrophy or disciform scar with foveal involvement, evidence of visually significant cataract (> grade 2), and adequate peripheral vision in the non-surgical eye. It is a Class III device authorized under FDA PMA P050034.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Implantable Miniature Telescope indicated for?

    The Implantable Miniature Telescope is indicated for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe 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.

  • What models of the Implantable Miniature Telescope are approved?

    The approved models are the IMT Wide Angle 2.2X and IMT Wide Angle 2.7X, as specified in the approval statement for the device.

  • What patient criteria must be met before implantation of the IMT?

    Patients must have retinal findings of geographic atrophy or disciform scar with foveal involvement, evidence of visually significant cataract (> grade 2), agree to pre-surgery training and assessment (typically 2 to 4 sessions) with low-vision specialists, achieve at least a 5-letter improvement on the ETDRS chart with an external telescope, have adequate peripheral vision in the eye not scheduled for surgery, and agree to postoperative visual training with a low vision specialist.