SUPARTZ FX
FDA premarket approval P980044/S028 · decided 2016-01-27
Approval details
- PMA number
- P980044
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUPARTZ FX
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2015-10-30
- Decision date
- 2016-01-27
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR RELOCATION OF MANUFACTURING PROCESSES FOR SUPARTZ FX TO A NEW FACILITY WITHIN THE MANUFACTURING PLANT FOR THE PRODUCT, AS WELL AS A CONCURRENT CHANGE TO THE CONTAINER CLOSURE SYSTEM FOR THE PRODUCT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |