- Device
- Ophthalin, Anikavisc, Nuvisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P000046
- Supplement
- S030
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2021-12-22
- Decision code
- APPR
- Date received
- 2021-11-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of the labeling change to update labels of OPHTHALIN® to identify Carl Zeiss Canada Ltd. as a Private Label Manufacturer and Distributor.