PMA P050034S009
- Device
- IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
- Applicant
- Samsara Vision, Inc.
- PMA number
- P050034
- Supplement
- S009
- Product code
- NCJ
- Decision date
- 2013-11-05
- Classification
- Telescope, Implantable, Miniature
- Generic name
- Telescope, implantable, miniature
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE APPROVED PROFESSIONAL USE INFORMATION AND PATIENT INFORMATION BOOKLET TO ADD INFORMATION OBTAINED FROM POST-APPROVAL STUDY IMT-002-LTME.
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
- S009
- Product code
- NCJ
- Generic name
- Telescope, implantable, miniature
- Decision date
- 2013-11-05
- Decision code
- APPR
- Date received
- 2013-05-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE APPROVED PROFESSIONAL USE INFORMATION AND PATIENT INFORMATION BOOKLET TO ADD INFORMATION OBTAINED FROM POST-APPROVAL STUDY IMT-002-LTME.