JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
FDA premarket approval P050047/S052 · decided 2016-04-29
Approval details
- PMA number
- P050047
- Supplement
- S052
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2016-04-04
- Decision date
- 2016-04-29
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for changes to the Directions for Use and Patient Labeling including updated postmarket surveillance data as well as other changes to harmonize pertinent content across Juvederm labeling documents. Minor typographical revisions and clarifications are also included.
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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 |