Nuvisc, Anikavisc, Ophthalin
FDA premarket approval P000046/S029 · decided 2021-10-21
Approval details
- PMA number
- P000046
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nuvisc, Anikavisc, Ophthalin
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2021-07-29
- Decision date
- 2021-10-21
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- Approval for request of an additional tradename, OPHTHALIN®
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Integrity™ Implant (K250997) | Anika Therapeutics, Inc. | 2025-06-17 |
| Tactoset® Injectable Bone Substitute (K231968) | Anika Therapeutics, Inc. | 2023-12-20 |
| Integrity Implant (K223538) | Anika Therapeutics, Inc. | 2023-08-17 |
| Integrity™ Bone Staple Fixation System (K223860) | Anika Therapeutics, Inc. | 2023-05-22 |
| Anika Tissue Tack Fixation System (K222487) | Anika Therapeutics, Inc. | 2023-05-08 |
| Tactoset (K223915) | Anika Therapeutics, Inc. | 2023-03-29 |
| Tactoset Injectable Bone Substitute (K212083) | Anika Therapeutics, Inc. | 2021-08-31 |
| SCS 17-01 (K190956) | Anika Therapeutics, Inc. | 2020-01-30 |