PMA P050034S020
- Device
- Implantable Miniature Telescope (IMT)
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S020
- Product code
- NCJ
- Decision date
- 2019-03-22
- Classification
- Telescope, Implantable, Miniature
- Generic name
- Telescope, implantable, miniature
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Implantable Miniature Telescope (IMT)
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S020
- Product code
- NCJ
- Generic name
- Telescope, implantable, miniature
- Decision date
- 2019-03-22
- Decision code
- APPR
- Date received
- 2018-09-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.