FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Acid, Hyaluronic, Intraarticular
PMA: P080020
·
Supplement: S055
·
Decision Apr 9, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Acid, Hyaluronic, Intraarticular
- Trade Name
- GEL-ONE
- PMA Number
- P080020
- Supplement Number
- S055
- 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
- April 9, 2026
- Date Received
- March 12, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval of site change for manufacturing of device component
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 |