Transcription of WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems
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WaveWriter Alpha and WaveWriter Alpha Prime SystemsInformation for Prescribers92395224-01 Content: MP92395224-01 REV B CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a for PrescribersWaveWriter Alpha & WaveWriter Alpha Prime Systems Information for Prescribers 92395224-01 ii of ivGuaranteesBoston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating are for illustration purposes Alpha is a trademark of Boston Scientific Corporation or its other trademarks are the property of their respective Bluetooth word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc.
Failure of the external electrical components will not result in an unacceptable risk to the user. System Clinical Summary Determination of the safety and effectiveness of the WaveWriter Alpha and WaveWriter Alpha Prime Systems was based on available published clinical studies for similar implanted spinal cord stimulation systems.
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