Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack
FDA premarket approval P200032/S004 · decided 2025-12-18
Approval details
- PMA number
- P200032
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack
- Generic name
- Transcatheter septal occluder (atrial)
- Applicant
- Occlutech Holding AG
- Date received
- 2025-11-14
- Decision date
- 2025-12-18
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- OZG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Schaffhausen
- 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
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