Food and Drug Administration
Circulatory System Devices panel
September 10, 2001
Briefing Information
FDA Summary for AMPLATZER® Septal Occluder and Delivery System Presentation ppt htm
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
AGA Medical Corporation
DRAFT The AMPLATZER® Septal Occluder and Delivery System, Instructions for Use pdf doc
DRAFT Physicians Manual pdf doc
DRAFT Summary of Safety and Effectiveness Data for P000039 pdf doc
FDA Summary for CardioSEAL® Septal Occlusion System with Qwik Load, NMT Medical P000049 ppt htm
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
NMT Medical Inc.
Draft Instructions for Use pdf doc