IMPLANTABLE MINIATURE TELESCOPE (IMT)
FDA premarket approval P050034 · decided 2010-07-01
Approval details
- PMA number
- P050034
- Trade name
- IMPLANTABLE MINIATURE TELESCOPE (IMT)
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2005-09-09
- Decision date
- 2010-07-01
- Days to decision
- 1756 days
- Decision code
- APPR
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Far Hills, NJ
- 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, ASDETER
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