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: LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
• Applicant: Abbott; 6035 stoneridge dr.; pleasanton, CA 94588
• HDE Number: H070004
• Supplement Number: S001
• Date Received: 10/24/2008
• Decision Date: 05/22/2009
• Advisory Committee: Cardiovascular
• Supplement Type: normal 75 day track
• Supplement Reason: other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study protocol.