|Trade Name||VITALITY FAMILY|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||cardiac resynchronization therapy defibrillator (crt-d) system|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes for the vitality and contak renewal families of defibrillators: 1) require the reed switch component supplier to expose 100% of the components to a high magnetic field condition of minimum of 30mt, 10 cycles with 1 second duration prior to shipping to guidant. 2) apply an enhanced quality test of 30mt through 30 cycles and verify the reed switch is open after removing the device from the magnetic field, to all devices currently held under a stop action notice (san).