IMPLANTABLE MINIATURE TELESCOPE (IMT)
FDA premarket approval P050034/S017 · decided 2016-10-20
Approval details
- PMA number
- P050034
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMPLANTABLE MINIATURE TELESCOPE (IMT)
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2016-09-26
- Decision date
- 2016-10-20
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- Modification to the inspection method for the optical surface of the telescope.
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