PMA P050034S012
- Device
- IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S012
- Product code
- NCJ
- Decision date
- 2014-01-15
- Classification
- Telescope, Implantable, Miniature
- Generic name
- Telescope, implantable, miniature
- Approval order statement
- POSSIBILITY OF REWORK AND RETESTING ACTIVITIES.
Current openFDA PMA Record#
- Device
- IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S012
- Product code
- NCJ
- Generic name
- Telescope, implantable, miniature
- Decision date
- 2014-01-15
- Decision code
- OK30
- Date received
- 2013-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- POSSIBILITY OF REWORK AND RETESTING ACTIVITIES.