Food and Drug Administration

Circulatory System Devices panel

September 10, 2001

Briefing Information

P000039 AMPLATZER® Septal Occluder and Delivery System

FDA Summary for AMPLATZER® Septal Occluder and Delivery System Presentation ppt   htm

FDA Summaries   pdf   doc

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

P000049 CardioSEAL® Septal Occlusion System with Qwik Load

FDA Summary for CardioSEAL® Septal Occlusion System with Qwik Load, NMT Medical P000049   ppt   htm

FDA Summaries   pdf   doc

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