|
Device | iStent inject Trabecular Micro-Bypass System |
Generic Name | Intraocular pressure lowering implant |
Applicant | Glaukos Corporation 229 Avenida Fabricante San Clemente, CA 92672 |
PMA Number | P170043 |
Supplement Number | S006 |
Date Received | 03/03/2020 |
Decision Date | 04/30/2020 |
Product Code |
OGO |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) protocol. |