OPTIVISC
FDA premarket approval P000046/S016 · decided 2010-02-12
Approval details
- PMA number
- P000046
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPTIVISC
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2009-10-02
- Decision date
- 2010-02-12
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR REVISIONS TO THE LABELING TO REFLECT A NEW DISTRIBUTOR NAME AND TO CHANGE THE TRADE NAME TO OPTIVISC.
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