PMDA device listing

エンドタック リライアンス SG DF-4(条件付MRI 対応)

PMDA Medical device listing · 22200BZX00593000 · Class IV

Key facts

PMDA document key 300500_22200BZX00593000_A_01
Brand names エンドタック リライアンス SG DF-4(条件付MRI 対応)
General names (JMDN) 植込み型除細動器・ペースメーカリード
Product type Medical device
Device class (Japan) Class IV
Approval, certification or notification number 22200BZX00593000
JMDN codes 36241000
Category code A0700
Marketing authorization holder 製造販売/(文献請求先も同じ)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 Oct 9, 2026
Latest revision 2024-10
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 10–99 Package insert revisions
  • None 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:

Browse all PMDA medical device and IVD listings (Japan)