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DevicePMAs@therightstef:P890055_S032 JSONTXT

Approval for a new adhesive to secure the antenna and modification to the piezo actuator release specification. the device, as modified, will be marketed under the trade name medstream programmable infusion system and is indicated for the chronic intrathecal infusion of baclofen injection sterile solution (5.0 ph to 7.0 ph) in the treatment of severe spasticity.

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