Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC
FDA premarket approval P110033/S069 · decided 2023-05-03
Approval details
- PMA number
- P110033
- Supplement
- S069
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2023-04-04
- Decision date
- 2023-05-03
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for revisions to the clinician labeling and patient labeling of Juvéderm Ultra, Ultra XC, and Ultra Plus XC, Juvéderm Ultra XC, Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, and Juvéderm Volux XC as a result of postmarket surveillance data.
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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 |