Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
ApplicantAdvanced Bifurcation Systems, Inc.
7419 Southfront Rd.
Livermore, CA 94551
PMA NumberP210014
Date Received04/01/2021
Decision Date12/13/2021
Withdrawal Date03/14/2023
Product Code NIQ 
Docket Number 21M-1321
Notice Date 12/16/2021
Advisory Committee Cardiovascular
Clinical TrialsNCT01788150
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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:  S001 S002 
-
-