§ 870.3650 - Pacemaker polymeric mesh bag.

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Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a pacemaker pulse generator. The bag is designed to create a stable implant environment for the pulse generator.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.