RADIESSE INJECTABLE IMPLANT 1.5CC, 8071M0, RADIESSE INJECTABLE IMPLANT 0.8 CC, 8069M0, RADIESSE INJECTABLE IMPLANT- 0.3C
FDA premarket approval P050037/S034 · decided 2012-10-17
Approval details
- PMA number
- P050037
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Trade name
- RADIESSE INJECTABLE IMPLANT 1.5CC, 8071M0, RADIESSE INJECTABLE IMPLANT 0.8 CC, 8069M0, RADIESSE INJECTABLE IMPLANT- 0.3C
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2012-09-20
- Decision date
- 2012-10-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- ADDITION OF DEFECT CATEGORIES TO THE INCOMING INSPECTION PROCEDURES BASED ON RISK AND COMMENSURATE WITH SEVERITY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |