PMA P170034S002

Device
Hydrus Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S002
Product code
OGO
Decision date
2019-12-10
Generic name
Intraocular pressure lowering implant
Approval order statement
Approval for a manufacturing site located at Norman Noble, Inc.; 5507 Avion Park Drive; Highland Heights, Ohio 44143, Contract Manufacturer (microstent).

Current openFDA PMA Record#

Device
Hydrus Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S002
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2019-12-10
Decision code
APPR
Date received
2019-07-24
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Norman Noble, Inc.; 5507 Avion Park Drive; Highland Heights, Ohio 44143, Contract Manufacturer (microstent).