Occlutech® ASD Occluder and Occlutech® Pistol Pusher
FDA premarket approval P200032 · decided 2023-12-29
Approval details
- PMA number
- P200032
- Trade name
- Occlutech® ASD Occluder and Occlutech® Pistol Pusher
- Generic name
- Transcatheter septal occluder (atrial)
- Applicant
- Occlutech Holding AG
- Date received
- 2020-07-07
- Decision date
- 2023-12-29
- Days to decision
- 1270 days
- Decision code
- APPR
- Product code
- OZG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Schaffhausen
- Statement
- The Occlutech ASD Occluder is a medical device intended for transcatheter closure of ostium secundum-type atrial septal defects (ASD). Patients indicated for ASD closure have: Echocardiographic evidence of ostium secundum-type ASD, Clinical evidence of right ventricular (RV) volume overload (hemodynamically significant left-to-right shunt with Qp / Qs ? 1.5 or RV enlargement).The Occlutech Pistol Pusher is a percutaneous, transcatheter pusher system designed for the delivery of the Occlutech
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