PMA P050034S019

Device
Implantable Miniature Telescope
Applicant
Samsara Vision, Inc.
PMA number
P050034
Supplement
S019
Product code
NCJ
Decision date
2017-10-20
Classification
Telescope, Implantable, Miniature
Generic name
Telescope, implantable, miniature
Approval order statement
Alternate supplier for a component of the telescope sub-assembly for Models Wide Angle 2.2X and Wide Angle 2.7X.

Current openFDA PMA Record#

Device
Implantable Miniature Telescope
Applicant
Samsara Vision, Inc.
PMA number
P050034
Supplement
S019
Product code
NCJ
Generic name
Telescope, implantable, miniature
Decision date
2017-10-20
Decision code
OK30
Date received
2017-09-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate supplier for a component of the telescope sub-assembly for Models Wide Angle 2.2X and Wide Angle 2.7X.