Intraocular Pressure Lowering Implant
Basic Information
- Device Name
- Intraocular Pressure Lowering Implant
- Trade Name
- GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- PMA Number
- P080030
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- OGO
- Generic Name
- Intraocular pressure lowering implant
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 16, 2014
- Date Received
- September 30, 2014
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE MODIFICATIONS TO THE MODEL GTS100I INSERTER AND STENT, WHICH COMPRISE THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM. THE MODIFICATIONS INCLUDE THEFOLLOWING:1) CHANGES TO THE INSERTER TO INCLUDE:A) A LARGER SLEEVE DIAMETER FOR INCREASED RIGIDITY OF THE SLIDE ASSEMBLY;B) AN INCREASE IN THE INTERNAL SPRING FORCE; C) A CHANGE TO THE GEOMETRY AND EXTENSION OF THE GRASPING TINES ON THE END OF THE SLOTTED TUBE; D) A RE-DESIGN OF THE RELEASE BUTTON ROCKER MECHANISM; AND E) COLOR CHANGES TO TWO OUTER INSERTER COMPONENTS (REAR HOUSING AND TRIGGER BUTTON).2) CHANGES TO THE STENT TO INCLUDE:A) AN INCREASE IN THE WALL THICKNESS OF THE SNORKEL BY TIGHTENING THE DIMENSIONAL TOLERANCE FROM A RANGE 0.155 TO 0.200 MM TO A RANGE OF 0.170 TO 0.200 MM; AND B) REMOVAL OF THE STENTING HEIGHT PARAMETER FROM THE FINISHED DEVICE DRAWINGS 10-0018 AND 10-0019 AS A CRITICAL DIMENSION.3) CHANGES TO THE STENT SYSTEM TO INCLUDE:A) A CHANGE FROM STERILIZATION FOLLOWING PRIMARY PACKAGING TO STERILIZATION FOLLOWING FINAL PACKAGING; AND B) ELIMINATION OF THE IN-PROCESS GRIP FORCE TESTING STEP.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OGO | Intraocular Pressure Lowering Implant | FDA class 3 | Unknown |