PMA P000046S031
- Device
- Ophthalin; Nuvisc; Anikavisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P000046
- Supplement
- S031
- Product code
- LZP
- Decision date
- 2025-10-15
- Classification
- Ophthalmic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- a replacement adhesive laminate film for the sealed pouch used as a sterile barrier system for the subject ophthalmic viscosurgical device
Current openFDA PMA Record#
- Device
- Ophthalin; Nuvisc; Anikavisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P000046
- Supplement
- S031
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2025-10-15
- Decision code
- OK30
- Date received
- 2025-09-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a replacement adhesive laminate film for the sealed pouch used as a sterile barrier system for the subject ophthalmic viscosurgical device