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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceBioFreedom Drug Coated Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantBiosensors International USA, Inc.
1013 Centre Rd.
Suite 228
Wilmington, DE 19805
PMA NumberP190020
Date Received08/16/2019
Decision Date04/14/2022
Withdrawal Date 10/05/2023
Product Code NIQ 
Docket Number 22M-0601
Notice Date 07/27/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT02843633
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the BioFreedom Drug Coated Stent System. This device is indicated for improving coronary luminal diameter in patients at high risk for bleeding with symptomatic ischemic heart disease due to de novo lesions of length <= 32 mm in native coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  
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