Juvederm Injectable Gel Implants
FDA premarket approval P050047/S069 · decided 2019-07-03
Approval details
- PMA number
- P050047
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Juvederm Injectable Gel Implants
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2019-04-05
- Decision date
- 2019-07-03
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the implementation of the International Council for Harmonisation (ICH) elemental impurities guideline by the raw material supplier for the hyaluronic acid and lidocaine hydrochloride used in the manufacture of the Juvéderm Injectable Gel Implants.
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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 |