SUPARTZ FX
FDA premarket approval P980044/S025 · decided 2015-05-20
Approval details
- PMA number
- P980044
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SUPARTZ FX
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2015-04-07
- Decision date
- 2015-05-20
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR A CHANGE OF THE TRADE NAME OF YOUR DEVICE FROM SUPARTZ TO SUPARTZ FX. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUPARTZ FX AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE, NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |