RADIESSE INJECTABLE IMPLANT
FDA premarket approval P050052/S018 · decided 2009-02-03
Approval details
- PMA number
- P050052
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RADIESSE INJECTABLE IMPLANT
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2008-12-09
- Decision date
- 2009-02-03
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL FOR: 1. CHANGING THE FILL VOLUME FROM A MAXIMUM DELIVERABLE FILL VOLUME OF 1.3 CC TO A MAXIMUM DELIVERABLE FILL VOLUME OF 1.5 CC.2. CHANGING THE SYRINGE BARREL HANDLE FROM A MOLDED STRAIGHT HANDLE TO A MOLDED HANDLE WITH AN ERGONOMIC CURVED HANDLE.3. MODIFICATION TO THE INSTRUCTION FOR USE TO INCLUDE THE 1.5 CC FILL VOLUME IN THE DEVICEDESCRIPTION SECTION OF THE INSTRUCTIONS FOR USE.4. CREATION OF PACKAGE LABELING SPECIFIC TO THE 1.5 CC FILL VOLUME, IDENTICAL TO THE PACKAGE LABELING FOR
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |