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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNIT-OCCLUD PDA
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantPfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad, CA 92008
PMA NumberP120009
Supplement NumberS004
Date Received01/12/2023
Decision Date10/17/2024
Product Code MAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the Nit-Occlud PDA PAS Study
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