- Device
- Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack
- Applicant
- Occlutech Holding AG
- PMA number
- P200032
- Supplement
- S003
- Product code
- OZG
- Generic name
- Transcatheter septal occluder (atrial)
- Decision date
- 2025-11-24
- Decision code
- APPR
- Date received
- 2025-08-29
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in the minimum recommended French sizes of the Occlutech Delivery Set III (ODS III) compatible with most Occlutech ASD Occluder sizes