RADIESSE INJECTABLE IMPLANT
FDA premarket approval P050037/S028 · decided 2012-06-20
Approval details
- PMA number
- P050037
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- 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
- 2011-03-30
- Decision date
- 2012-06-20
- Days to decision
- 448 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL FOR THE ADDITION OF SAFETY AND EFFECTIVENESS CLINICAL DATA AND POST-MARKETING SURVEILLANCE DATA FROM THE POST APPROVAL STUDIES PERFORMED AS A CONDITION OF APPROVAL FOR THE RADIESSE INJECTABLE IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME RADIESSE INJECTABLE IMPLANT AND IS INDICATED FOR SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS AND IT IS ALSO INTENDED FOR RESTORATION AND/OR CORRECTION OF TH
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |