SUPARTZ
FDA premarket approval P980044/S003 · decided 2006-01-20
Approval details
- PMA number
- P980044
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SUPARTZ
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2004-09-14
- Decision date
- 2006-01-20
- Days to decision
- 493 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR LABELING CHANGES INCLUDING MODIFYING THE DIRECTIONS FOR USE SECTION TO INCLUDE A STATEMENT REGARDING THE USE OF A COURSE OF 3 INJECTIONS, AND ADDING INFORMATION ABOUT ADVERSE EVENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |