Ophthalin, Anikavisc, Nuvisc
FDA premarket approval P000046/S030 · decided 2021-12-22
Approval details
- PMA number
- P000046
- Supplement
- S030
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ophthalin, Anikavisc, Nuvisc
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2021-11-23
- Decision date
- 2021-12-22
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- Approval of the labeling change to update labels of OPHTHALIN® to identify Carl Zeiss Canada Ltd. as a Private Label Manufacturer and Distributor.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |