RADIESSE (+) 0.8CC, RADIESSE (+) 1.5CC
FDA premarket approval P050052/S073 · decided 2016-05-02
Approval details
- PMA number
- P050052
- Supplement
- S073
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RADIESSE (+) 0.8CC, RADIESSE (+) 1.5CC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2015-09-25
- Decision date
- 2016-05-02
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for using an alternate supplier for the syringe barrels and assembly of the syringe components.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |