RADIESSE® Injectable Implant
FDA premarket approval P050037/S133 · decided 2023-12-07
Approval details
- PMA number
- P050037
- Supplement
- S133
- Supplement type
- 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
- 2023-11-13
- Decision date
- 2023-12-07
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Change to the Calcium Hydroxylapatite (CaHA) particle manufacturing process to allow for an additional pathway to process CaHA particle byproducts.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |