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Emergency/Compassionate Use - AMPLATZER Duct Occluder
Expanded access is no longer available for this treatment.
Sponsored by: AGA Medical Corporation
Information provided by: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00583583
  Purpose

Emergency/compassionate use for the AMPLATZER Duct Occluder


Condition Intervention
Patent
Ductus
Arteriosus
 Device: Device closure with the AMPLATZER Duct Occluder

U.S. FDA Resources
Study Type: Expanded Access

Further study details as provided by AGA Medical Corporation:

Intervention Details:
    Device: Device closure with the AMPLATZER Duct Occluder
    Device closure with the AMPLATZER Duct Occluder
  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Emergency/compassionate use for patients not meeting the inclusion crtieria for the AMPLATZER Duct Occluder clinical trial
  Contacts and Locations
No Contacts or Locations Provided
  More Information

FDA PMA Approval  This link exits the ClinicalTrials.gov site

Responsible Party: AGA Medical Corporation ( Ken Lock )
Study ID Numbers: AGA-004 E/C, G980103
Study First Received: December 20, 2007
Last Updated: December 28, 2007
ClinicalTrials.gov Identifier: NCT00583583  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Emergencies

ClinicalTrials.gov processed this record on January 16, 2009



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