| 产品名称 | SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY™ SHIELD Everolimus-Eluting Plat |
|---|---|
| 申请号 | P150003 S093 |
| 申请类型 | 暂无权限 |
| 产品分类 | 暂无权限 |
| 分类名称 | Coronary Drug-Eluting Stent |
| 产品分类码 | NIQ |
| 申请企业 | BOSTON SCIENTIFIC CORPORATION |
| 申请企业/街道1 | One Scimed Place |
| 申请企业/城市 | Maple Grove |
| 申请企业/州 | MN |
| 申请企业/邮编zip | 55311 |
| 审查/咨询委员会 | 心血管 |
| 审查/咨询委员会(英文) | Cardiovascular |
| 审查/咨询委员会代码 | CV |
| PMA决定类型 | Approval: PMA has been approved. |
| 批准声明 | Approval for changes to the labeling, device packaging, and addition of the 48 mm device delivery system to allow for alignment of the product matrix to include the 48-mm stent size. |
| 是否为组合产品 | Yes |
| 加急审查 | No |
| 补充类型 | real time process |
| 补充原因 | Change Design/Components/Specifications/Material |
| 接收日期 | 2023-03-14 |
| 决定日期 | 2023-06-12 |
