PMDA device listing

NeuRx 横隔膜ペーシングシステム(電極デリバリーツール)

PMDA Medical device listing · 22900BZX00328000 · Class IV

Key facts

PMDA document key 820792_22900BZX00328000_C_01
Brand names NeuRx 横隔膜ペーシングシステム(電極デリバリーツール)
General names (JMDN) 横隔神経電気刺激装置
Product type Medical device
Device class (Japan) Class IV
Approval, certification or notification number 22900BZX00328000
JMDN codes 35652000
Category code A1200
Marketing authorization holder 製造販売/USCIジャパン株式会社
Package insert date Jul 12, 2021
Latest revision 2021-07
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:

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