- Device
- Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack
- Applicant
- Occlutech Holding AG
- PMA number
- P200032
- Supplement
- S001
- Product code
- OZG
- Generic name
- Transcatheter septal occluder (atrial)
- Decision date
- 2024-06-07
- Decision code
- APPR
- Date received
- 2024-03-08
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for extending the shelf-life for both the Occlutech ASD Occluder (ASD) and the Occlutech Pistol Pusher (OPP) to 5 years