Premarket Approval (PMA)

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.

• Device: Resolute Integrity Zotarolimus-Eluting Coronary Stent System
• Generic Name: Coronary drug-eluting stent
• Applicant: Medtronic Vascular; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P110013
• Supplement Number: S091
• Date Received: 09/17/2018
• Decision Date: 12/20/2018
• Withdrawal Date: 05/14/2026
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to reduce the duration of follow-up from 5 years to 3 years.