FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Implant, Dermal, For Aesthetic Use
PMA: P050037
·
Supplement: S150
·
Decision Mar 18, 2026
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
- P050037
- Supplement Number
- S150
- 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
- March 18, 2026
- Date Received
- February 17, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
the implementation of a new, alternate, GMP Equipment Washer to increase mixing components washing capacity
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 |