Radiesse (+) Injectable Implant
FDA premarket approval P050052/S129 · decided 2021-09-01
Approval details
- PMA number
- P050052
- Supplement
- S129
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Radiesse (+) Injectable Implant
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2020-12-03
- Decision date
- 2021-09-01
- Days to decision
- 272 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for Radiesse (+) injectable implant for expanding the indications to include deep injection (subdermal and/or supraperiosteal) for soft tissue augmentation to improve moderate to severe loss of jawline contour in adults over the age of 21
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |