PMA P000046S029

Device
Nuvisc, Anikavisc, Ophthalin
Applicant
Anika Therapeutics, Inc.
PMA number
P000046
Supplement
S029
Product code
LZP
Decision date
2021-10-21
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Approval for request of an additional tradename, OPHTHALIN®

Current openFDA PMA Record#

Device
Nuvisc, Anikavisc, Ophthalin
Applicant
Anika Therapeutics, Inc.
PMA number
P000046
Supplement
S029
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2021-10-21
Decision code
APPR
Date received
2021-07-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for request of an additional tradename, OPHTHALIN®