RADIESSE (+) LIDOCAINE DERMAL FILTER
FDA premarket approval P050052/S052 · decided 2015-01-30
Approval details
- PMA number
- P050052
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RADIESSE (+) LIDOCAINE DERMAL FILTER
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2014-04-09
- Decision date
- 2015-01-30
- Days to decision
- 296 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL FOR MODIFICATION TO THE FORMULATION, SYRINGE MATERIAL, SPECIFICATIONS, MANUFACTURING PROCESS AND LABELING TO SUPPORT THE ADDITION OF THE LIDOCAINE AND IMPROVE MANUFACTURING EFFICACY. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME,RADIESSE® (+) AND IS INDICATED FOR SUB-DERMAL IMPLANTATION THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, INCLUDING NASOLABIAL FOLDS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |