| 产品名称 | Revanesse Versa, Revanesse Versa+ with Lidocaine, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.2 mL, Revane |
|---|---|
| 申请号 | P160042 S020 |
| 申请类型 | 暂无权限 |
| 产品分类 | 暂无权限 |
| 分类名称 | Implant, Dermal, For Aesthetic Use |
| 产品分类码 | LMH |
| 申请企业 | PROLLENIUM MEDICAL TECHNOLOGIES INC. |
| 申请企业/街道1 | 138 INDUSTRIAL PARKWAY NORTH |
| 申请企业/城市 | AURORA |
| 申请企业/邮编zip | L4G 4 |
| 审查/咨询委员会 | 普通外科与整形外科 |
| 审查/咨询委员会(英文) | General & Plastic Surgery |
| 审查/咨询委员会代码 | SU |
| PMA决定类型 | 30 day notice |
| 批准声明 | Change to the stopper, which is a component of the syringe system of the 1.0 and 1.2mL configurations of Revanesse Versa, Revanesse Versa+ with Lidocaine, and Revanesse Lips+ with Lidocaine. |
| 是否为组合产品 | No |
| 加急审查 | No |
| 补充类型 | 30 day notice |
| 补充原因 | process change - manufacturer/sterilizer/packager/supplier |
| 接收日期 | 2023-02-21 |
| 决定日期 | 2023-03-22 |
