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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.
 
DeviceSLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex
Generic NameCoronary drug-eluting stent
ApplicantSvelte Medical Systems, Inc.
675 Central Avenue, Suite 2
New Providence, NJ 07974
PMA NumberP210014
Date Received04/01/2021
Decision Date12/13/2021
Withdrawal Date 03/14/2023
Product Code NIQ 
Docket Number 21M-1321
Notice Date 12/16/2021
Advisory Committee Cardiovascular
Clinical TrialsNCT01788150
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System. The device is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions <= 24 mm in length in native coronary arteries with >= 2.25 mm to <= 4.00 mm reference vessel diameters, using direct stenting or pre-dilatation interventional techniques. DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions <= 34 mm in length in native coronary arteries with >= 2.25 mm to <= 4.00 mm reference vessel diameters, using direct stenting or pre-dilatation interventional techniques.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S001  
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