GEL-ONE
FDA premarket approval P080020 · decided 2011-03-22
Approval details
- PMA number
- P080020
- Trade name
- GEL-ONE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2008-07-31
- Decision date
- 2011-03-22
- Days to decision
- 964 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR THE GEL-ONE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO NON-PHARMACOLOGIC THERAPY, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) OR 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 |