PMA P170034S006

Device
Hydrus Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S006
Product code
OGO
Decision date
2021-01-07
Generic name
Intraocular pressure lowering implant
Approval order statement
Reduction in sampling from 100% to AQL sampling plans specified by the sponsor.

Current openFDA PMA Record#

Device
Hydrus Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S006
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2021-01-07
Decision code
OK30
Date received
2020-12-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Reduction in sampling from 100% to AQL sampling plans specified by the sponsor.