HYALGAN
FDA premarket approval P950027/S010 · decided 2008-01-08
Approval details
- PMA number
- P950027
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYALGAN
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici S.P.A.
- Date received
- 2007-12-07
- Decision date
- 2008-01-08
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES IN THE LABEL: 1) THE ADDITION OF THE TRADE NAME, HYALECTIN, FOR SODIUM HYALURONATE IN THE DEVICE DESCRIPTION; AND 2) MODIFICATIONS TO THE CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS TO ENHANCE THE APPROPRIATE USAGE OF THE DEVICE.
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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 |