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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, 2014]
[CITE: 21CFR870.3700]
See Related Information on Pacemaker programmers. 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. 870.3700 Pacemaker programmers.

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

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

(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 20, 2012, for any pacemaker programmer that was in commercial distribution before May 28, 1976, or that has, on or before September 20, 2012, been found to be substantially equivalent to any pacemaker programmer that was in commercial distribution before May 28, 1976. Any other pacemaker programmer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 FR 37573, June 22, 2012]

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