IMPLANTABLE MINIATURE TELESCOPE (IMT)
FDA premarket approval P050034/S016 · decided 2016-12-20
Approval details
- PMA number
- P050034
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMPLANTABLE MINIATURE TELESCOPE (IMT)
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2016-09-23
- Decision date
- 2016-12-20
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- Approval for a design change to reposition the eyelet on each haptic (loop) of the carrier of the IMT to the distal end of the haptic.
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