Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC
FDA premarket approval P110033/S033 · decided 2018-01-04
Approval details
- PMA number
- P110033
- Supplement
- S033
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2017-08-21
- Decision date
- 2018-01-04
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for implementation of a scaled-up manufacturing process for the Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC dermal fillers
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 |
|---|---|---|
| NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229) | Allergan | 2021-06-02 |
| TrueTear Intranasal Tear Neurostimulator (K193589) | Allergan | 2020-08-31 |
| Natrelle 133 Plus MICROCELL Tissue Expander (K180826) | Allergan | 2018-12-21 |
| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| TrueTear Intranasal Tear Neurostimulator (DEN170086) | Allergan | 2018-05-17 |
| SERI SURGICAL SCAFFOLD (K123128) | Allergan | 2013-04-25 |