Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack
FDA premarket approval P200032/S001 · decided 2024-06-07
Approval details
- PMA number
- P200032
- Supplement
- S001
- 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
- 2024-03-08
- Decision date
- 2024-06-07
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- OZG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Schaffhausen
- Statement
- Approval for extending the shelf-life for both the Occlutech ASD Occluder (ASD) and the Occlutech Pistol Pusher (OPP) to 5 years
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.