MONOVISC
FDA premarket approval P090031/S003 · decided 2015-02-04
Approval details
- PMA number
- P090031
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MONOVISC
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2014-11-07
- Decision date
- 2015-02-04
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL TO EXPAND THE SPECIFICATION FOR RESIDUAL METHANOL INMONOVISC FROM <= 0.05% TO <= 0.03% W/W TO BE IN ACCORDANCE WITH RESIDUAL SOLVENT TESTING LIMITS UNDER USP GENERAL CHAPTER <467>, TO REVISE THE STABILITY TESTING PROTOCOL FOR MONOVISC, AND TO EXTEND THE SHELF LIFE OF MONOVISC FROM 2 YEARS TO 3 YEARS UTILIZING THIS REVISED STABILITY TESTINGPROTOCOL.
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 |