FDA.reportPublic FDA data

PMA P080030S012

Device
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Applicant
Glaukos Corporation
PMA number
P080030
Supplement
S012
Product code
OGO
Decision date
2014-12-16
Classification
Intraocular Pressure Lowering Implant
Generic name
Intraocular pressure lowering implant
Approval order 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.

Current openFDA PMA Record#

Device
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Applicant
Glaukos Corporation
PMA number
P080030
Supplement
S012
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2014-12-16
Decision code
APPR
Date received
2014-09-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order 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.