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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 21 - 40 of 52
Object Description Object Status Safety Topic / Subject

Atriasept Closure Device
Cardia, Inc.
Eagan, MN


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

Bard Clamshell Septal Umbrella
17 mm, occluder (MP35N)
C.R. Bard, Inc.
Billerica, MA



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

Bard Clamshell Septal Umbrella
23 mm, occluder (MP35N)
C.R. Bard, Inc.
Billerica, MA



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

Bard Clamshell Septal Umbrella
28 mm, occluder (MP35N)
C.R. Bard, Inc.
Billerica, MA



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

Bard Clamshell Septal Umbrella
33 mm, occluder (MP35N)
C.R. Bard, Inc.
Billerica, MA



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

Bard Clamshell Septal Umbrella
40 mm, occluder (MP35N)
C.R. Bard, Inc.
Bellerica, MA



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

BioSTAR Septal Repair Implant
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...

BioTREK
PFO closure device
NMT Medical
Boston, MA



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

CardioSEAL Septal Repair Implant
NMT Medical, Inc.
Boston, MA

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

Celt ACD Vascular Closure Device
Vasorum, www.vasorum.ie

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

Cocoon Septal Occluder
Nitinol, Platinum
Vascular Innovations Co. Ltd
Nonthaburi, Thailand



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

Figulla Flex II ASD Occluder
All Sizes
Occlutech GmbH, 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...

GORE CARDIOFORM Septal Occluder
W. L. Gore and Associates, Inc., www.wlgore.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...

GORE HELEX Septal Occluder
W.L. Gore & Associates
www.GoreMedical.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...

Intrasept
patent foramen ovale (PFO) closure device
Nitinol, Titanium
Cardia Inc.
Burnsville, M




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

Lock Clamshell Septal 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...

Lock Clamshell Septal Occlusion Implant
23 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...

Lock Clamshell Septal Occlusion Implant
28 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...

Lock Clamshell Septal Occlusion Implant
33 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...

Lock Clamshell Septal Occlusion Implant
40 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...


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  © 2004- by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. (v3.1.109)