Implantable Miniature Telescope (IMT)
FDA premarket approval P050034/S020 · decided 2019-03-22
Approval details
- PMA number
- P050034
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Implantable Miniature Telescope (IMT)
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2018-09-11
- Decision date
- 2019-03-22
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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