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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.
 
DeviceSLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste
Generic NameCoronary drug-eluting stent
ApplicantAdvanced Bifurcation Systems, Inc.
7419 Southfront Rd.
Livermore, CA 94551
PMA NumberP210014
Supplement NumberS001
Date Received01/12/2022
Decision Date04/08/2022
Withdrawal Date03/14/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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