SUPARTZ
FDA premarket approval P980044/S024 · decided 2015-03-31
Approval details
- PMA number
- P980044
- Supplement
- S024
- 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
- 2014-11-24
- Decision date
- 2015-03-31
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND THE PATIENT INFORMATION (PI) FOR SUPARTZ AS FOLLOWS:1) REVISION IN THE IFU AND PI OF THE STATEMENT, ¿THE SAFETY AND EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF SUPARTZ HAVE NOT BEEN ESTABLISHED.¿ TO ¿THE EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF SUPARTZ HAS NOT BEEN ESTABLISHED.¿; AND 2) INSERTION IN THE IFU AND PI OF THE STATEMENTS, ¿ADVERSE EXPERIENCE DATA FROM THE LITERATURE CONTAIN NO EVIDENCE OF INCREASED SAFETY RISK RELATING TO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |