Acid, Hyaluronic, Intraarticular
Basic Information
- Device Name
- Acid, Hyaluronic, Intraarticular
- Trade Name
- SUPARTZ
- PMA Number
- P980044
- Supplement Number
- S024
- Device Class
- FDA Class 3
- Product Code
- MOZ
- Generic Name
- Acid, hyaluronic, intraarticular
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 31, 2015
- Date Received
- November 24, 2014
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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 RETREATMENT WITH SUPARTZ. THE FREQUENCY AND SEVERITY OF ADVERSE EVENTS OCCURRING DURING REPEAT TREATMENT CYCLES DID NOT INCREASE OVER THAT REPORTED FOR A SINGLE TREATMENT CYCLE.¿
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOZ | Acid, Hyaluronic, Intraarticular | FDA class 3 | Unknown |