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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameNIT-OCCLUD PDA
Classification Nameoccluder, patent ductus, arteriosus
ApplicantPFM MEDICAL, INC
PMA NumberP120009
Date Received05/04/2012
Decision Date08/16/2013
Product Code
MAE[ Registered Establishments with MAE ]
Docket Number 13M-0988
Notice Date 08/26/2013
Advisory Committee Cardiovascular
Clinical Trials NCT00828334
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the nit-occlud® pda. This device is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter less than 4 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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