Radiesse® Injectable Implant
FDA premarket approval P050037/S126 · decided 2023-06-08
Approval details
- PMA number
- P050037
- Supplement
- S126
- Supplement type
- Special (Immediate 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
- 2023-05-09
- Decision date
- 2023-06-08
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for revisions to the clinician labeling and patient labeling as a result of postmarket surveillance data.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |