JUVEDERM HYALURONATE GEL IMPLANTS
FDA premarket approval P050047/S024 · decided 2012-04-16
Approval details
- PMA number
- P050047
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- JUVEDERM HYALURONATE GEL IMPLANTS
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Allergan
- Date received
- 2012-03-29
- Decision date
- 2012-04-16
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- REVIEW TO INCREASE THE NUMBER OF SYRINGES DRIED IN THE DRYING OVENS AND HARMONIZE THE NUMBER OF SYRINGES DRIED PER DRYING CYCLE WITH THE NUMBER OF SYRINGES STERILIZED PER STERILIZATION CYCLE.
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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 |