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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.
 
DeviceSvelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut
Generic NameCoronary drug-eluting stent
ApplicantAdvanced Bifurcation Systems, Inc.
7419 Southfront Rd.
Livermore, CA 94551
PMA NumberP210014
Supplement NumberS002
Date Received03/14/2023
Decision Date04/06/2023
Withdrawal Date03/14/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT01788150
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 to terminate of both PAS clinical studies, PAS001 continued follow-up of OPTIMIZE Clinical Study and PAS002 DIRECT IV Study
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