PMA P050034S004
- Device
- IMPLANTABLE MINIATURE TELESCOPE
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S004
- Product code
- NCJ
- Decision date
- 2011-02-04
- Classification
- Telescope, Implantable, Miniature
- Generic name
- Telescope, implantable, miniature
- Approval order statement
- APPROVAL FOR EXTENDING THE SHELF LIFE OF THE IMT FROM 2 YEARS TO 3 YEARS.
Current openFDA PMA Record#
- Device
- IMPLANTABLE MINIATURE TELESCOPE
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S004
- Product code
- NCJ
- Generic name
- Telescope, implantable, miniature
- Decision date
- 2011-02-04
- Decision code
- APPR
- Date received
- 2010-12-15
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EXTENDING THE SHELF LIFE OF THE IMT FROM 2 YEARS TO 3 YEARS.