NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
FDA premarket approval P040046/S027 · decided 2018-06-27
Approval details
- PMA number
- P040046
- Supplement
- S027
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2017-12-18
- Decision date
- 2018-06-27
- Days to decision
- 191 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval to implement an additional incoming specification, i.e., verify the color of the gel material by using the Ultra Scan VIS Sensor System to confirm that the gel color does not change between shipment and receipt. There are no changes to existing incoming specification, manufacturing process, and final device specifications. The addition of this assessment is specific to the 900 Parkway Global Park, La Aurora, Heredia, Costa Rica manufacturing site.
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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 |