C.F.R. » Title 21 » 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

21 C.F.R. § 870.3680

Cardiovascular permanent or temporary pacemaker electrode

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(a) Temporary pacemaker electrode—(1) Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

(2) Classification. Class II (performance standards).

(b) Permanent pacemaker electrode—(1) Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

(2) 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 October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device 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 39927, July 6, 2012]
Notes of Decisions
Cited in 3 cases, 1994–1995 · leading case: MARTINEZ-CARABALLO v. Intermedics, Inc., 886 F. Supp. 974 (D.P.R. 1995).
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MARTINEZ-CARABALLO v. Intermedics, Inc., 886 F. Supp. 974 (D.P.R. 1995). “3610 and 21 CFR § 870.3680 . In general, manufacturers of Class III devices must obtain approval from the Federal Drug Administration (“FDA”) prior to marketing those devices.”
Fogal v. Steinfeld, 163 Misc. 2d 497 (N.Y. Sup. Ct. 1994). “3610, which appears to deal with pulse generators rather than with pacemaker leads (see, 21 CFR 870.3680 [b]; 21 CFR 805.3 [d]), asserts that Medtronic model No.”
Berger v. Medtronic, Inc., 164 Misc. 2d 378 (N.Y. Sup. Ct. 1995). “The only regulation specifically pertaining to pacemaker leads appears at 21 CFR 870.3680 (b). Inasmuch as this section only identifies pacemaker leads as a "permanent pacemaker electrode”, and classifies such devices as a class III device requiring premarket approval, the court…”
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