PMDA device listing
SpaceOAR システム
PMDA Medical device listing · 22900BZI00017000 · Class IV
Key facts
| PMDA document key | 300500_22900BZI00017000_A_01 |
|---|---|
| Brand names | SpaceOAR システム |
| General names (JMDN) | 放射線治療用吸収性組織スペーサ |
| Product type | Medical device |
| Device class (Japan) | Class IV |
| Approval, certification or notification number | 22900BZI00017000 |
| JMDN codes | 60424004 |
| Category code | B0400 |
| Marketing authorization holder | 製造販売／ボストン・サイエンティフィックジャパン株式会社 |
| Package insert date | Nov 21, 2025 |
| Latest revision | 2025-11 |
| PMDA product page | pmda.go.jp |
| Package insert on pmda.go.jp | pmda.go.jp |
At a glance
- 10–99 Package insert revisions
- 1–9 Related PMDA documents
- Listed Listed on the PMDA site
- No 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: