Radiesse Injectable Implant, Radiesse Hands, Radiesse (+) Lidocaine, Radiesse (+) Jawline
FDA premarket approval P050052/S150 · decided 2023-07-12
Approval details
- PMA number
- P050052
- Supplement
- S150
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Radiesse Injectable Implant, Radiesse Hands, Radiesse (+) Lidocaine, Radiesse (+) Jawline
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2023-06-16
- Decision date
- 2023-07-12
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval to implement a new in-process test for the calcium hydroxyapatite (CaHA) particle manufacturing process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |