HYALGAN(R)
FDA premarket approval P950027 · decided 1997-05-28
Approval details
- PMA number
- P950027
- Trade name
- HYALGAN(R)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici S.P.A.
- Date received
- 1995-07-28
- Decision date
- 1997-05-28
- Days to decision
- 670 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THEKNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY, AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HyaloGYN Vaginal Moisturizing Suppositories (K191052) | Fidia Farmaceutici S.P.A. | 2020-01-09 |
| HyaloGYN Vaginal Hydrating Gel (K150883) | Fidia Farmaceutici S.P.A. | 2015-09-01 |
| HYALO GYN (K094039) | Fidia Farmaceutici S.P.A. | 2010-05-07 |