PMA P050034S005

Device: IMPLANTABLE MINIATURE TELESCOPE (IMT)
Applicant: Samsara Vision, Inc.
PMA number: P050034
Supplement: S005
Product code: NCJ
Decision date: 2011-03-31
Classification: Telescope, Implantable, Miniature
Generic name: Telescope, implantable, miniature
Approval order statement: CHANGE THE BIOLOGICAL INDICATOR USED IN THE STERILIZATION PROCESS AND TO ADD AN OPTION FOR A SECOND FULL CYCLE STERILIZATION (DOUBLE STERILIZATION) TO THE MANUFACTURING PROCESS IF REQUIRED.

Current openFDA PMA Record#

Device: IMPLANTABLE MINIATURE TELESCOPE (IMT)
Applicant: Samsara Vision, Inc.
PMA number: P050034
Supplement: S005
Product code: NCJ
Generic name: Telescope, implantable, miniature
Decision date: 2011-03-31
Decision code: OK30
Date received: 2011-03-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE THE BIOLOGICAL INDICATOR USED IN THE STERILIZATION PROCESS AND TO ADD AN OPTION FOR A SECOND FULL CYCLE STERILIZATION (DOUBLE STERILIZATION) TO THE MANUFACTURING PROCESS IF REQUIRED.