PMA P000046S027
- Device
- Ophthalmic Viscoelastic
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P000046
- Supplement
- S027
- Product code
- LZP
- Decision date
- 2019-08-28
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Approval for an extension of the shelf-life of Ophthalmic Viscoelastic® from 24 months to 36 months.
Current openFDA PMA Record#
- Device
- Ophthalmic Viscoelastic
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P000046
- Supplement
- S027
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2019-08-28
- Decision code
- APPR
- Date received
- 2019-05-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an extension of the shelf-life of Ophthalmic Viscoelastic® from 24 months to 36 months.