Catheter, Balloon For Retinal Reattachment

Device Code: 4430

Product Code(s): LOG

Device Classification Information

Device Type ID4430
Device NameCatheter, Balloon For Retinal Reattachment
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 CodeLOG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4430
DeviceCatheter, Balloon For Retinal Reattachment
Product CodeLOG
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:48:59

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