PMA P050034S006

Device: IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X
Applicant: Samsara Vision, Inc.
PMA number: P050034
Supplement: S006
Product code: NCJ
Decision date: 2012-02-23
Classification: Telescope, Implantable, Miniature
Generic name: Telescope, implantable, miniature
Approval order statement: APPROVAL FOR THE ADDITION OF THE INFORMATION REGARDING THE SAFETY OF THE DEVICE DURING MRI EXPOSURE TO THE PATIENT INFORMATION BOOKLET.

Current openFDA PMA Record#

Device: IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X
Applicant: Samsara Vision, Inc.
PMA number: P050034
Supplement: S006
Product code: NCJ
Generic name: Telescope, implantable, miniature
Decision date: 2012-02-23
Decision code: APPR
Date received: 2011-12-27
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE INFORMATION REGARDING THE SAFETY OF THE DEVICE DURING MRI EXPOSURE TO THE PATIENT INFORMATION BOOKLET.