PMA P050034S010
- Device
- IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X & WIDE ANGLE2.7X
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S010
- Product code
- NCJ
- Decision date
- 2013-08-09
- Classification
- Telescope, Implantable, Miniature
- Generic name
- Telescope, implantable, miniature
- Approval order statement
- ADD AN ASSEMBLY JIG INTO THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X & WIDE ANGLE2.7X
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S010
- Product code
- NCJ
- Generic name
- Telescope, implantable, miniature
- Decision date
- 2013-08-09
- Decision code
- OK30
- Date received
- 2013-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ASSEMBLY JIG INTO THE MANUFACTURING PROCESS.