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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNIT-OCCLUD PDA
Classification Nameoccluder, patent ductus, arteriosus
Generic Nameoccluder, patent ductus, arteriosus
Applicant
PFM MEDICAL, INC
1815 aston ave
suite 106
carlsbad, CA 92008
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
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 MINIMUMANGIOGRAPHIC DIAMETER LESS THAN 4 MM.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 
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