Humanitarian Device Exemption (HDE)

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

• Trade Name: GRAFTMASTER CORONARY STENT GRAFT SYSTEM
• Classification Name: stent, coronary
• Generic Name: stent, coronary
• Applicant: Abbott Vascular Devices; 26531 ynez rd.; temecula, CA 92591
• HDE Number: H000001
• Supplement Number: S013
• Date Received: 08/27/2014
• Decision Date: 09/25/2014
• Product Code: MAF [ Registered Establishments with MAF ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change to the pyrogen testing process.