SUPARTZ JOINT FLUID THERAPY
FDA premarket approval P980044/S009 · decided 2009-07-08
Approval details
- PMA number
- P980044
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUPARTZ JOINT FLUID THERAPY
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2009-02-26
- Decision date
- 2009-07-08
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR A DISTRIBUTION SITE CHANGE FROM ONE ADDRESS IN MEMPHIS, TENNESSEE TO ANOTHER ADDRESS IN MEMPHIS, TENNESSEE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |