SUPARTZ FX
FDA premarket approval P980044 · decided 2001-01-24
Approval details
- PMA number
- P980044
- Trade name
- SUPARTZ FX
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 1998-12-01
- Decision date
- 2001-01-24
- Days to decision
- 785 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR THE SUPARTZ(TM) DISPO. THE DEVICE 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 |