PMDA device listing

プロキシメイト リニヤー ステイプラー II(本体及び交換用カートリッジ)

PMDA Medical device listing · 21900BZX00885000 · Class III

Key facts

PMDA document key 340216_21900BZX00885000_A_06
Brand names プロキシメイト リニヤー ステイプラー II(本体及び交換用カートリッジ)
General names (JMDN) 体内固定用組織ステープル
Product type Medical device
Device class (Japan) Class III
Approval, certification or notification number 21900BZX00885000
JMDN codes 35615003
Category code A3000
Marketing authorization holder 製造販売/ジョンソン・エンド・ジョンソン株式会社
Package insert date Oct 26, 2017
Latest revision 2017-05
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)