21 C.F.R. § 870.3620 Pacemaker lead adaptor.
Title 21 - Food and Drugs
(a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.” [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001]
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices
§ 870.3620 Pacemaker lead adaptor.
