Gel-One
FDA premarket approval P080020/S053 · decided 2025-01-17
Approval details
- PMA number
- P080020
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Gel-One
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2024-12-19
- Decision date
- 2025-01-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- The sharing of the existing h-HAD (Gel-One intermediate) manufacturing equipment in Preparation Building-1 in the SKK Takahagi Plant currently used to manufacture Hyaluronic Acid extracted from chicken combs (existing h-Had) along with h-HAD made from Hyaluronic Acid extracted from bacterial fermentation (FHA-h-HAD). The existing validated cleaning method will be used for the shared equipment to assure the cleanliness and minimize risks of cross-contamination of FHA-h-HAD to the existing h-HAD p
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |