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HSA · registration DE0509900

Abbott Medical Amplatzer Muscular VSD Occluder

SingaporeCardiovascularClass DAbbott Medical
Official record identity
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
Classification
Risk class
Class D
Official value: CLASS D
Published category
Cardiovascular
Published parties
Product owner
Abbott Medical
Registrant / registration holder
ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
Official description

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.

Additional source fields
Product owner address
5050 Nathan Lane North, Plymouth, MN 55442, United States
Registrant address
3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
About this record

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.