Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Generic NameIntraocular pressure lowering implant
ApplicantGlaukos Corporation
26051 Merit Cir.
Suite 103
Laguna Hills, CA 92653
PMA NumberP080030
Supplement NumberS012
Date Received09/30/2014
Decision Date12/16/2014
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
-
-