RADIESSE INJECTABLE IMPLANT
FDA premarket approval P050052/S081 · decided 2016-01-20
Approval details
- PMA number
- P050052
- Supplement
- S081
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- RADIESSE INJECTABLE IMPLANT
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2015-12-11
- Decision date
- 2016-01-20
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:REVISIONS TO THE PATIENT DIARY, ENROLLMENT FORM AND RADIOLOGY FORM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |