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: VITALITY HE
• Classification Name: implantable pulse generator, pacemaker (non-crt)
• Generic Name: cardiac resynchronization therapy defibrillator (crt-d) system
• Applicant: GUIDANT CORP.
• PMA Number: P960040
• Supplement Number: S128
• Date Received: 05/23/2006
• Decision Date: 06/22/2006
• Product Code: LWP [ Registered Establishments with LWP ]
• Advisory Committee: Cardiovascular
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to add warning regarding correct device implant orientation.