FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Acid, Hyaluronic, Intraarticular
PMA: P980044
·
Supplement: S065
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Acid, Hyaluronic, Intraarticular
- Trade Name
- SUPARTZ FX; VISCO-3
- PMA Number
- P980044
- Supplement Number
- S065
- Device Class
- FDA Class 3
- Product Code
- MOZ
- Generic Name
- Acid, hyaluronic, intraarticular
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 19, 2025
- Date Received
- November 25, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
discontinuation of antigenicity testing for the main component HA and the SUPARTZ device family as a lot release / quality control test
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 |