RADIESSE INJECTABLE IMPLANT
FDA premarket approval P050052/S019 · decided 2009-07-13
Approval details
- PMA number
- P050052
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RADIESSE INJECTABLE IMPLANT
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2009-01-14
- Decision date
- 2009-07-13
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILED INSTRUCTIONS FOR MIXING RADIESSE WITH 2% LIDOCAINE HCL (RESULTING IN A FINAL CONCENTRATION OF 0.3% LIDOCAINE) PRIOR TO INJECTION FOR THE INDICATED USE OF SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS. THE MIXING OF RADIESSE AND LIDOCAINE IS TO BE ACCOMPLISHED USING A MIXING KIT THAT WILL BE MADE AVAILABLE SEPARATE FROM THE RADIESSE DEVICE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |