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 Rapid Exchange Coronary Stent System
• Generic Name: Coronary drug-eluting stent
• Applicant: Medtronic Vascular; 3576 Unocal Place; Santa Rosa, CA 95403
• PMA Number: P110013
• Supplement Number: S103
• Date Received: 07/10/2020
• Decision Date: 10/05/2020
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval for site change for packaging and labeling rework processes.