MONOVISC
FDA premarket approval P090031/S006 · decided 2016-02-25
Approval details
- PMA number
- P090031
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MONOVISC
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2016-02-10
- Decision date
- 2016-02-25
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- Approval for adding the following language to the Instructions for Use (IFU): Intra-articular injection of sodium hyaluronate preparations has occasionally been associated with allergic/anaphylactic reactions and transient hypotension, which have generally resolved spontaneously or after conservative treatment.
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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 |