Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack
FDA premarket approval P200032/S003 · decided 2025-11-24
Approval details
- PMA number
- P200032
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2025-08-29
- Decision date
- 2025-11-24
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- OZG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Schaffhausen
- 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
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.