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Safety Topic [191]

Safety Info ID# Safety Topic / Subject Article Text
191 Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices

Cardiac occluders and closure devices are implants used to treat patients with patent ductus arteriosus (PDA), atrial septal defect (ASD), ventricular septal defect (VSD), or patent foramen ovale (PFO

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Displaying 41 - 52 of 52
Object Description Object Status Safety Topic / Subject

Nexus Septal Occluder
W.L. Gore & Associates, www.goremedical.com

1.5,3 Conditional 8 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Nit-Occlud PDA-R Occluder
PFM s.r.l.

3 Conditional 6 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Occlutech Muscular VSD (mVSD) Occluder
Occlutech Ltd., www.occlutech.com

1.5, 3 Conditional 5 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Occlutech PDA Occluder
Occlutech, www.occlutech.com

1.5,3 Conditional 8 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Occulotech LAA Occluder
Occlutech, www.occlutech.com

1.5,3 Conditional 8 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Perimembranous Ventricular Septal Defect (PmVSD) Occluder
Occlutech, www.occlutech.com

1.5, 3 Conditional 8 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Post Myocardial Infarction Ventricular Septal Defect (PIVSD) Occluder
Occlutech, www.occlutech.com

1.5, 3 Conditional 8 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Premere PFO Closure System
patent foramen ovale (PFO) closure device
St. Jude Medical
www.sjmprofessional.com



3 Conditional 5 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Rashkind PDA Occlusion Implant
12 mm, occluder (304V SS)
C.R. Bard, Inc.
Billerica, MA



1.5 Conditional 5 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Rashkind PDA Occlusion Implant
17 mm, occluder (304 V SS)
C.R. Bard, Inc.
Billerica, MA



1.5 Conditional 5 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

STARFlex Septal Repair Implant
MP35N, Nitinol
NMT Medical, Inc.
Boston, MA



3 Safe More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...

Ultrasept PFO Occluder
Cardia, Inc., www.cardiainc.com

3 Conditional 6 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More...


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