NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
FDA premarket approval P040046 · decided 2013-02-20
Approval details
- PMA number
- P040046
- Trade name
- NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Allergan
- Date received
- 2004-12-06
- Decision date
- 2013-02-20
- Days to decision
- 2998 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE NATRELLE® 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR WOMEN FOR THE FOLLOWING USES (PROCEDURES):1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY; AND 2) BREAST RECONSTRUCTION. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION
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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 |