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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

Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)P160042

就这个产品提问

Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)是一款玻尿酸填充产品，注册人 Prollenium Medical Technologies, Inc.。库里关联的注册证：美国 P160042。美国首次批准于 2017-08-04（P160042）。数据截至 2026-10-27。

  • 监管属性玻尿酸填充 · 监管属性未定
  • 注册人Prollenium Medical Technologies, Inc.
  • 辖区US
  • 档案更新于2026-10-27 · 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

Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)

产品
监管属性
未定（还没有核实过的注册证关联）未能核实
品类
玻尿酸填充
美国 · FDA PMA
P160042
证上名称
REVANESSE ULTRA
注册人
Prollenium Medical Technologies, Inc.
首次批准
2017-08-04
本证核发
2017-08-04
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。

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

    P160042 首次批准

  2. US

    P160042 · P160042/S016

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜Approval for the qualification of hyaluronic acid (HA) from a new supp…

  3. US

    P160042 · P160042/S026

    Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for standardizing the descriptive informa…

  4. US

    P160042 · P160042/S024

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for the addition of a mixer discharge…

  5. US

    P160042 · P160042/S029

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for modifications to cleanroom layout in a secondary manuf…

  6. US

    P160042 · P160042/S031

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜new polyvinyl chloride material used in secondary packaging for Rev…

  7. US

    P160042 · P160042/S032

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval to qualify a Third-Party Logistics (3PL) supplier for ware…

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。

交叉发现 · 价格观测

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最近变化

5
  • P160042：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-10-14
  • P160042：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜new pol…2026-05-08
  • P160042：30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approva…2025-12-22
  • P160042：135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2024-08-20
  • P160042：Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/…2024-07-12

资料

1