Regulatory Text
21 C.F.R. § 870.3620 — Pacemaker lead adaptor.
§ 870.3620 Pacemaker lead adaptor. (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, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001]
Source: ecfr.gov · govinfo.gov — public domain
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Citation
21 C.F.R. § 870.3620
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The regulatory text of 21 C.F.R. § 870.3620 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
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21 C.F.R. — public domain
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