PMDA device listing
植込み型補助人工心臓 HeartMateIIの付属品（モニタ関連の構成品：ディスプレイモジュール、システムモニタ）
PMDA Medical device listing · 22400BZI00017000 · Class IV
Key facts
| PMDA document key | 381005_22400BZI00017000_H_02 |
|---|---|
| Brand names | 植込み型補助人工心臓 HeartMateIIの付属品（モニタ関連の構成品：ディスプレイモジュール、システムモニタ） |
| General names (JMDN) | 植込み型補助人工心臓システム |
| Product type | Medical device |
| Device class (Japan) | Class IV |
| Approval, certification or notification number | 22400BZI00017000 |
| JMDN codes | 34941000 |
| Category code | A0700 |
| Marketing authorization holder | 製造販売／選任製造販売業者：アボットメディカルジャパン合同会社外国特例承認取得者：ソラテック社 |
| Package insert date | Nov 14, 2025 |
| Latest revision | 2021-08 |
| PMDA product page | pmda.go.jp |
| Package insert on pmda.go.jp | pmda.go.jp |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- Listed Listed on the PMDA site
- Yes Refers to a technical manual
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMDA medical device and IVD listings (Japan)
Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date: