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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR870.3600]
See Related Information on External pacemaker pulse generator. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 870 -- CARDIOVASCULAR DEVICES

Subpart D--Cardiovascular Prosthetic Devices

Sec. 870.3600 External pacemaker pulse generator.

(a)Identification. An external pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

(b)Classification. Class III (premarket approval).

(c)Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See 870.3.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 78 FR 18234, Mar. 26, 2013]

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