Radiesse Injectable Implant
FDA premarket approval P050037/S099 · decided 2020-12-21
Approval details
- PMA number
- P050037
- Supplement
- S099
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Radiesse Injectable Implant
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2019-10-23
- Decision date
- 2020-12-21
- Days to decision
- 425 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval to implement campaign filling of up to six gel bowls into a single lot of sterilized units for the Radiesse and Radiesse (+) Lidocaine injectable implant products.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |