Abbott Medical Amplatzer Muscular VSD Occluder
- Registration number
- DE0509900
- Model name
- Amplatzer Muscular VSD Occluder; Amplatzer Muscular VSD Occluder; Amplatzer Muscular VSD Occluder; Amplatzer Muscular VSD Occluder; Amplatzer Muscular VSD Occluder; Amplatzer Muscular VSD Occluder; Amplatzer Muscular VSD Occluder; Amplatzer Muscular VSD Occluder
- Model identifier
- 9-VSD-MUSC-004; 9-VSD-MUSC-006; 9-VSD-MUSC-008; 9-VSD-MUSC-010; 9-VSD-MUSC-012; 9-VSD-MUSC-014; 9-VSD-MUSC-018; 9-VSD-MUSD-016
- Registration date
- October 11, 2024
- Risk class
- Class D
- Product owner
- Abbott Medical
- Registrant / registration holder
- ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
The Amplatzer Muscular VSD Occluder are percutaneous, transcatheter, ventricular septal defect closure devices designed for the occlusion of muscular ventricular septal defects. Inclusion Criteria • Patients with demonstrated muscular ventricular septal defects either by echocardiography or left ventriculography. • A distance of 3 mm of the muscular communication to the ventricular apex. • Body weight >8 kgs. • Ventricular communications with or without pulmonary hypertension and acyanosis. • Patients who underwent surgical closure of ventricular septal defects and have a residual left to-right shunt. • Patients with previous myocardial infarctions and ventricular septal defect.
- Product owner address
- 5050 Nathan Lane North, Plymouth, MN 55442, United States
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.