FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Implant, Dermal, For Aesthetic Use
PMA: P050052
·
Supplement: S173
·
Decision Dec 12, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Implant, Dermal, For Aesthetic Use
- Trade Name
- RADIESSE INJECTABLE IMPLANT
- PMA Number
- P050052
- Supplement Number
- S173
- Device Class
- FDA Class 3
- Product Code
- LMH
- Generic Name
- Implant, dermal, for aesthetic use
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 12, 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
The new Clean-In-Place (CIP) Spray Dryer System which automatically dose a measured amount of phosphoric acid to wash solution is approved.
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 |
|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | FDA class 3 | Unknown |