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产品档案由注册证、说明书原文与平台整理数据生成

NatrelleNatrelle 410 Highly Cohesive Silicone-Filled Breast Implants

就这个产品提问

Natrelle是一款乳房植入物产品（三类医疗器械），注册人 艾尔建Allergan。库里关联的注册证：美国 P040046、美国 P020056。美国首次批准于 2013-02-20（P040046）。数据截至 2026-11-09。

  • 监管属性乳房植入物 · 三类医疗器械
  • 注册人艾尔建Allergan
  • 辖区US
  • 档案更新于2026-11-09 · v1

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注册与基本资料

Natrelle

产品
监管属性
三类医疗器械
品类
乳房植入物
美国 · FDA PMA
P040046
美国 · FDA PMA
P020056
证上名称
NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
注册人
Allergan
首次批准
2013-02-20
官网核对
还没有与官网现页逐字段核对

公开信息：注册证原文字段。注册人与日期取自 P040046；共关联 2 张证。

说明书对照（分辖区）

同一属性在不同辖区说明书里的原文；没写的标「原文未报告」，不适用的标「不适用」

暂无数据

注册时间线

  1. US

    P020056 首次批准

  2. US

    P040046 首次批准

  3. US

    P040046 · P040046/S026

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Implement an Electronic Data Acquisition (EDA) System to collect cy…

  4. US

    P040046 · P040046/S027

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval to implement an additional incoming s…

  5. US

    P040046 · P040046/S029

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Replace paper chart recorders and to use an electric heating module…

  6. US

    P040046 · P040046/S030

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Implementing changes to the gel filling process, specifically, chan…

  7. US

    P040046 · P040046/S032

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Addition of an alternative detection method for the Quality Control…

  8. US

    P040046 · P040046/S031

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval of the revised protocol for the post-approval study (PAS) protocol.

  9. US

    P020056 · P020056/S059

    Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for modifications to Physician and Patient Labeli…

  10. US

    P020056 · P020056/S061

    Normal 180 Day Track No User Fee｜Labeling Change - PAS｜Approval for including the final results from the BIFS-001 NBIR-Arm Clinical Study in…

  11. US

    P020056 · P020056/S063

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜The 30 Day notice is to notify FDA of the commissioning of the new …

  12. US

    P020056 · P020056/S050

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜acknowledgement of a submission that includes the BIFS-001: BIFS-arm Final Stud…

  13. US

    P020056 · P020056/S065

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes to the adhesive coating that is used to secure the lids to …

  14. US

    P020056 · P020056/S064

    Normal 180 Day Track No User Fee｜Labeling Change - PAS｜approval for revised labeling to include the results of the BIFS Arm study.

分开写首次批准、本证核发（延续或变更后会更新）、变更与有效期；首次批准为空表示未从官方来源取到。每张证只列最近 6 条变更，完整记录点编号看注册证原文。海外证的日期照原文的叫法：英国器械是登记日期（MHRA 不审批），澳大利亚是列入 ARTG 的日期，FDA 器械是决定日期。

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最近变化

5
  • P020056：Normal 180 Day Track No User Fee｜Labeling Change - PAS｜approval for revised labe…2026-09-29
  • P020056：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes…2024-12-16
  • P020056：Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜acknowledgement of …2024-08-16
  • P020056：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜The 30 …2024-06-21
  • P020056：Normal 180 Day Track No User Fee｜Labeling Change - PAS｜Approval for including th…2023-07-12

资料

2