NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
FDA premarket approval P040046/S009 · decided 2015-03-13
Approval details
- PMA number
- P040046
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Allergan
- Date received
- 2014-09-15
- Decision date
- 2015-03-13
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE FOLLOWING PACKAGING AND MANUFACTURING CHANGES:1) MODIFICATION OF THE PRIMARY INNER AND OUTER TRAY PACKAGING TO INCLUDE TWO FINGER TABS;2) MODIFICATION OF THE OUTER TRAY TO INCLUDE TWO CAVITIES;3) A CHANGE OF THE POLYCARBONATE TRAY MATERIAL TO GEOX PEEREX® 51 PC POLYCARBONATE FILM TO BE SUPPLIED BY PRENT THERMOFORMING;4) PRIMARY LID PACKAGING THAT IS LARGER WITH BLUE INK ARROWS; 5) LARGER SECONDARY PACKAGING BOXES TO HOUSE THE LARGER TRAYS;6) A CHANGE TO A SEPARATE TAMPER EVIDENT
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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 |