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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.
 
DeviceXIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS018
Date Received05/29/2012
Decision Date10/05/2012
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ALLOW THE CORRESPONDING DRUG CONTENT VALUES TO BE CENTERED AROUND 100% LABEL CLAIM AND PROVIDE INCREASED PROBABILITY THAT INDIVIDUAL UNITS WILL HAVE A DRUG CONTENT OF GREATER THAN 90% OF THE LABELED CLAIM TO MEET THE CONDITION OF APPROVAL THAT "WITHIN 12 MONTHS OF PMA APPROVAL, YOU SHOULD SUBMIT A PMA SUPPLEMENT REQUESTING APPROVAL TO TIGHTEN THE IN-PROCESS COATING WEIGHT GAIN SPECIFICATION OR IMPLEMENT PROCEDURES TO RE-COAT STENTS WITH LESS THAN 95% COATING WEIGHT GAIN UPON IN-PROCESS INSPECTION. THE COMPANY HAS PROVIDED THE ALTERNATIVE SOLUTION.
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