JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC
FDA premarket approval P050047/S030 · decided 2013-03-11
Approval details
- PMA number
- P050047
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2012-12-26
- Decision date
- 2013-03-11
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN EXTENSION OF THE SHELF-LIFE FROM 18 MONTHS TO 20MONTHS FOR THE 1ML SYRINGE; AN INCREASE IN THE ONOETHYLGLYCINEXYLIDIDE (MEGX) IMPURITY SPECIFICATION FROM 2.5% TO 3.5% W/W OF THE LABEL STRENGTH AND TOTAL IMPURITIES FROM 3.0% TO 4.3% OF LABEL STRENGTH.
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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 |