Occlutech® ASD Occluder and Occlutech® Pistol Pusher
FDA premarket approval P200032/S002 · decided 2025-04-18
Approval details
- PMA number
- P200032
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Occlutech® ASD Occluder and Occlutech® Pistol Pusher
- Generic name
- Transcatheter septal occluder (atrial)
- Applicant
- Occlutech Holding AG
- Date received
- 2025-03-21
- Decision date
- 2025-04-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OZG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Schaffhausen
- 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
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