SUPARTZ FX
FDA premarket approval P980044/S064 · decided 2025-08-18
Approval details
- PMA number
- P980044
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUPARTZ FX
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2025-07-30
- Decision date
- 2025-08-18
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- for the sharing of existing SUPARTZ device family manufacturing equipment in Preparation Building-4 in the SKK Takahagi Plant for the manufacture of the FHA-SUPARTZ device family using hyaluronic acid derived from bacterial fermentation
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 |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |