Telescope, Implantable, Miniature

Device Code: 4447

Product Code(s): NCJ

Device Classification Information

Device Type ID4447
Device NameTelescope, Implantable, Miniature
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Intraocular And Corneal Implants Devices Branch (ICIB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeNCJ
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4447
DeviceTelescope, Implantable, Miniature
Product CodeNCJ
FDA Device ClassificationClass 3 Medical Device
Device Problems
Insufficient Information
2
Adverse Event Without Identified Device Or Use Problem
2
Break
1
Total Device Problems 5
TPLC Last Update: 2019-04-02 20:49:20

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