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.

Identification. A pacemaker programmer is a device used to change noninvasively one or more of the electrical operating characteristics of a pacemaker.

Classification. Class III (premarket approval).

Identification. A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.

Classification. Class III (premarket approval).

Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches, used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker 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.

Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.

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.

Identification. A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.

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.

Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.

Classification. Class II (performance standards).

Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Classification. Class II (special controls). The guidance document entitled "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" will serve as the special control. See 870.1 for the availability of this guidance document.

Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Classification. Class II (performance standards).

Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.

Classification. Class II (performance standards).