Ophthaalmic Viscoelastic
FDA premarket approval P000046/S026 · decided 2017-03-31
Approval details
- PMA number
- P000046
- Supplement
- S026
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ophthaalmic Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2017-02-14
- Decision date
- 2017-03-31
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- Approval for the addition of a new trade name, Ophthalmic Viscoelastic.
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