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 SYSTEMS
• Generic Name: Coronary drug-eluting stent
• Applicant: Medtronic Vascular; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P110013
• Supplement Number: S016
• Date Received: 06/17/2013
• Decision Date: 09/12/2013
• Withdrawal Date: 05/14/2026
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A REVISED ELUTION SPECIFICATION.