HYALGAN
FDA premarket approval P950027/S006 · decided 2005-07-19
Approval details
- PMA number
- P950027
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYALGAN
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici S.P.A.
- Date received
- 2005-01-07
- Decision date
- 2005-07-19
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- APPROVAL FOR MODIFYING THE SPECIFICATIONS FOR THE ACTIVE INGREDIENT (SODIUM HYALURONATE) BY ELIMINATING THE ABNORMAL TOXICITY TEST AND REPLACING THE RABBIT PYROGEN TEST WITH THE BACTERIAL ENDOTOXINS TEST (LIMULUS AMOEBOCYTE LYSATE (LAL) TEST) AND MODIFYING THE SPECIFICATIONS FOR THE FINISHED PRODUCT TO REPLACE THE RABBIT PYROGEN TEST WITH THE LAL TEST.
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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 |