PMA P200032

Device: Occlutech Pistol Pusher
Applicant: Occlutech Holding AG
Product code: OZG
Decision date: 2026-05-11
Generic name: Transcatheter septal occluder (atrial)
Approval order statement: Approval for a revised Instructions for Use (IFU) for the Occlutech Pistol Pusher (OPP). The updated IFU introduces generalized handling instructions to standardize procedures across Occlutech devices

Current openFDA PMA Record#

Device: Occlutech Pistol Pusher
Applicant: Occlutech Holding AG
PMA number: P200032
Supplement: S005
Product code: OZG
Generic name: Transcatheter septal occluder (atrial)
Decision date: 2026-05-11
Decision code: APPR
Date received: 2026-03-04
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a revised Instructions for Use (IFU) for the Occlutech Pistol Pusher (OPP). The updated IFU introduces generalized handling instructions to standardize procedures across Occlutech devices