PMA P200032
- Device
- Occlutech® ASD Occluder and Occlutech® Pistol Pusher
- Applicant
- Occlutech Holding AG
- Product code
- OZG
- Decision date
- 2026-06-05
- Generic name
- Transcatheter septal occluder (atrial)
- Approval order statement
- manufacturing site transfer of the Occlutech Distribution Center from Occlutech AB (Sweden) to Occlutech GmbH (Germany)
Current openFDA PMA Record#
- Device
- Occlutech® ASD Occluder and Occlutech® Pistol Pusher
- Applicant
- Occlutech Holding AG
- PMA number
- P200032
- Supplement
- S006
- Product code
- OZG
- Generic name
- Transcatheter septal occluder (atrial)
- Decision date
- 2026-06-05
- Decision code
- OK30
- Date received
- 2026-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing site transfer of the Occlutech Distribution Center from Occlutech AB (Sweden) to Occlutech GmbH (Germany)