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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.
 
DeviceResolute Integrity Zotarolimus-Eluting Coronary Stent Systems
Generic NameCoronary drug-eluting stent
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP110013
Supplement NumberS098
Date Received07/22/2019
Decision Date10/17/2019
Withdrawal Date05/14/2026
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for introducing changes to the material of the desiccant (molecular sieve material) added to the product packaging post sterilization of the Resolute Integrity product.
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