PMA P050034S016
- Device
- IMPLANTABLE MINIATURE TELESCOPE (IMT)
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S016
- Product code
- NCJ
- Decision date
- 2016-12-20
- Classification
- Telescope, Implantable, Miniature
- Generic name
- Telescope, implantable, miniature
- Approval order 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.
Current openFDA PMA Record#
- Device
- IMPLANTABLE MINIATURE TELESCOPE (IMT)
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S016
- Product code
- NCJ
- Generic name
- Telescope, implantable, miniature
- Decision date
- 2016-12-20
- Decision code
- APPR
- Date received
- 2016-09-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.