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: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM
• Generic Name: Coronary drug-eluting stent
• Applicant: Boston Scientific Corp; One Scimed Pl.; Maple Grove, MN 55311
• PMA Number: P110010
• Supplement Number: S061
• Date Received: 09/19/2013
• Decision Date: 10/18/2013
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.