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: EXPRESS MONORAIL OVER-THE-WIRE CORONARY STENT SYSTEM
• Classification Name: stent, coronary
• Generic Name: intravascular stent with delivery system
• Applicant: BOSTON SCIENTIFIC CORPORATION
• PMA Number: P020009
• Supplement Number: S085
• Date Received: 05/02/2012
• Decision Date: 05/30/2012
• Product Code: MAF [ Registered Establishments with MAF ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Removal of waist length in-process inspection steps.