- Device
- Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack
- Applicant
- Occlutech Holding AG
- PMA number
- P200032
- Supplement
- S004
- Product code
- OZG
- Generic name
- Transcatheter septal occluder (atrial)
- Decision date
- 2025-12-18
- Decision code
- OK30
- Date received
- 2025-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- consolidation of manufacturing operations for the Occlutech ASD Occluder by moving all remaining production activities and equipment from your 'TIP' (Technologie-und Innovationspark) facility to your 'BIZ' (Bioinstrumentezentrum) facility