RADIESSE
FDA premarket approval P050052/S036 · decided 2012-09-25
Approval details
- PMA number
- P050052
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RADIESSE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2012-07-20
- Decision date
- 2012-09-25
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL TO EXTEND THE LABELED SHELF LIFE OF THE 3.0CC PRODUCT FILL VOLUME RADIESSE FROM 6 MONTHS TO 24 MONTHS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |