BioFreedom Drug Coated Coronary Stent System

FDA Premarket Approval P190020

Pre-market Approval Supplement Details

DeviceBioFreedom Drug Coated Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantBiosensors International USA, Inc.1013 Centre Rd.suite 228wilmington, DE 19805 PMA NumberP190020 Date Received08/16/2019 Decision Date04/14/2022 Product Code NIQ  Advisory Committee Cardiovascular Clinical TrialsNCT02843633 Expedited Review Granted? No
Date Received2019-08-16
Decision Date2022-04-14
PMAP190020
SupplementS
Product CodeNIQ 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination ProductYes
Applicant AddressBiosensors International USA, Inc.
1013 Centre Rd.
suite 228
wilmington, DE 19805 PMA NumberP190020 Date Received08/16/2019 Decision Date04/14/2022 Product Code NIQ  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. Supplements:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P190020Original Filing

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