PMA P170034S001

Device
Hydrus Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S001
Product code
OGO
Decision date
2019-10-08
Classification
Intraocular Pressure Lowering Implant
Generic name
Intraocular pressure lowering implant
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device
Hydrus Microstent
Applicant
Alcon Research, LLC
PMA number
P170034
Supplement
S001
Product code
OGO
Generic name
Intraocular pressure lowering implant
Decision date
2019-10-08
Decision code
APPR
Date received
2018-09-07
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.