产品档案由注册证、说明书原文与平台整理数据生成
NatrelleNatrelle Saline-Filled Breast Implants
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 P990074。美国首次批准于 2000-05-10（P990074）。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
注册与基本资料公开可看；交叉发现与价格需要登录
注册与基本资料
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
- US
P990074 首次批准
- US
P990074 · P990074/S048
30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Installation of a new patch curing oven and electronic data acquisi…
- US
P990074 · P990074/S045
Normal 180 Day Track｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for changes to the patient and physician label…
- US
P990074 · P990074/S049
135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for a change to the annual re-validat…
- US
P990074 · P990074/S050
Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for modifications to Physician and Patient Labeli…
- US
P990074 · P990074/S053
30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜The 30 Day notice is to notify FDA of the commissioning of the new …
- US
P990074 · P990074/S054
30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes to the adhesive coating that is used to secure the lids to …
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。
交叉发现 · 价格观测
最近变化
5- P990074：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜changes…2024-12-16
- P990074：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜The 30 …2024-06-21
- P990074：Real-Time Process｜Labeling Change - Indications/instructions/shelf life/tradenam…2022-12-29
- P990074：135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2022-10-05
- P990074：Normal 180 Day Track｜Labeling Change - Indications/instructions/shelf life/trade…2021-10-27