DevicePMAs@therightstef:P950022_S014 11 Projects
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Approval for new defibrillation lead systems and accessories. The devices, as modified, will be marketed under the trade name riat series 1500 (models 1570, 1571, 1580 and 1581) defibrillation lead system and accessories (s-65-s, s-65-f, s-65-x, tx-070). These devices are indicated for use with compatible pulse generators (refer to the applicable defibrillator manual for system indications.). They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart.
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