|
Device | GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM |
Generic Name | Intraocular pressure lowering implant |
Applicant | GLAUKOS, CORPORATION 26051 MERIT CIRCLE, SUITE 103 LAGUNA HILLS, CA 92653 |
PMA Number | P080030 |
Supplement Number | S010 |
Date Received | 07/30/2013 |
Decision Date | 08/28/2013 |
Product Code |
OGO |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ELIMINATE COMPRESSED AIR CLEANING OF THE PACKAGE TRAYS AND ADDITION OF AN ALTERNATE TRAY VENDOR. |