Ophthalmic Viscoelastic
FDA premarket approval P000046/S027 · decided 2019-08-28
Approval details
- PMA number
- P000046
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ophthalmic Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2019-05-24
- Decision date
- 2019-08-28
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- Approval for an extension of the shelf-life of Ophthalmic Viscoelastic® from 24 months to 36 months.
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