PMA P080030S019

Device: GLAUKOS ISTENT TRABECULAR MICRO BYPASS STENT SYSTEM
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S019
Product code: OGO
Decision date: 2016-12-05
Classification: Intraocular Pressure Lowering Implant
Generic name: Intraocular pressure lowering implant
Approval order statement: Modifications to the clean room and moving of the purchasing controls, receiving acceptance, and final packaging/acceptance operations to the San Clemente manufacturing site.

Current openFDA PMA Record#

Device: GLAUKOS ISTENT TRABECULAR MICRO BYPASS STENT SYSTEM
Applicant: Glaukos Corporation
PMA number: P080030
Supplement: S019
Product code: OGO
Generic name: Intraocular pressure lowering implant
Decision date: 2016-12-05
Decision code: OK30
Date received: 2016-11-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modifications to the clean room and moving of the purchasing controls, receiving acceptance, and final packaging/acceptance operations to the San Clemente manufacturing site.