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: S077
• Date Received: 10/11/2016
• Decision Date: 01/13/2017
• Withdrawal Date: 05/14/2026
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Real-Time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for updates to the labeling to align with the current ACC/AHA guidelines on dual antiplatelet therapy.