PMDA device listing

一時ペーシングカテーテル

PMDA Medical device listing · 20500BZY00084000 · Class IV

Key facts

PMDA document key 400054_20500BZY00084000_A_01
Brand names 一時ペーシングカテーテル
General names (JMDN) 体外式ペースメーカ用心臓電極
Product type Medical device
Device class (Japan) Class IV
Approval, certification or notification number 20500BZY00084000
JMDN codes 70485100
Category code A0700
Marketing authorization holder 製造販売/大正医科器械株式会社
Package insert date Jul 25, 2023
Latest revision 2023-07
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None 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:

Browse all PMDA medical device and IVD listings (Japan)