Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)
• Classification Name: coronary drug-eluting stent
• Applicant: BOSTON SCIENTIFIC CORP.
• PMA Number: P110010
• Supplement Number: S029
• Date Received: 09/05/2012
• Decision Date: 09/21/2012
• Product Code: NIQ [ Registered Establishments with NIQ ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Use of new statistical process control software.