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: HEARTMATE II LVAS
• Classification Name: ventricular (assisst) bypass
• Applicant: THORATEC CORP.
• PMA Number: P060040
• Supplement Number: S013
• Date Received: 09/17/2010
• Decision Date: 10/08/2010
• Product Code: DSQ [ Registered Establishments with DSQ ]
• Advisory Committee: Cardiovascular
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for revised operator manual and patient handbook labeling for the device.