PMA P200032S002

Device: Occlutech® ASD Occluder and Occlutech® Pistol Pusher
Applicant: Occlutech Holding AG
PMA number: P200032
Supplement: S002
Product code: OZG
Decision date: 2025-04-18
Classification: Cardiovascular
Generic name: Transcatheter septal occluder (atrial)
Approval order statement: to add a new manufacturing location, ‘BIZ’ (Bioinstrumentezentrum), within the same currently-approved establishment (under same FEI) for the manufacture of the Occlutech ASD Occluder

Current openFDA PMA Record#

Device: Occlutech® ASD Occluder and Occlutech® Pistol Pusher
Applicant: Occlutech Holding AG
PMA number: P200032
Supplement: S002
Product code: OZG
Generic name: Transcatheter septal occluder (atrial)
Decision date: 2025-04-18
Decision code: OK30
Date received: 2025-03-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add a new manufacturing location, ‘BIZ’ (Bioinstrumentezentrum), within the same currently-approved establishment (under same FEI) for the manufacture of the Occlutech ASD Occluder