PMA P050034S015

Device: VISIONCARE IMPLANTABLE MINIATURE TELESCOPE
Applicant: Samsara Vision, Inc.
PMA number: P050034
Supplement: S015
Product code: NCJ
Decision date: 2015-01-27
Classification: Telescope, Implantable, Miniature
Generic name: Telescope, implantable, miniature
Approval order statement: APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY PROTOCOL: UPDATED STUDY PROTOCOL WITH THE INCLUSION OF CASE REPORT FORM (CRF) AND STUDY TIMELINE.

Current openFDA PMA Record#

Device: VISIONCARE IMPLANTABLE MINIATURE TELESCOPE
Applicant: Samsara Vision, Inc.
PMA number: P050034
Supplement: S015
Product code: NCJ
Generic name: Telescope, implantable, miniature
Decision date: 2015-01-27
Decision code: APPR
Date received: 2014-11-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol - OSB
Approval order statement: APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY PROTOCOL: UPDATED STUDY PROTOCOL WITH THE INCLUSION OF CASE REPORT FORM (CRF) AND STUDY TIMELINE.