RADIESSE® Injectable Implant
FDA premarket approval P050037/S115 · decided 2022-09-02
Approval details
- PMA number
- P050037
- Supplement
- S115
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RADIESSE® Injectable Implant
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2022-04-12
- Decision date
- 2022-09-02
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for the implementation of a different blender into the Calcium Hydroxylapatite (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 |