RADIESSE 1.3CC AND 0.3CC
FDA premarket approval P050037 · decided 2006-12-22
Approval details
- PMA number
- P050037
- Trade name
- RADIESSE 1.3CC AND 0.3CC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2005-09-29
- Decision date
- 2006-12-22
- Days to decision
- 449 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL FOR RADIESSE. THIS DEVICE IS INDICATED FOR SUBDERMAL IMPLANTATION FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |