21 CFR 870.3650
§ 870.3650 Pacemaker polymeric mesh bag.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.3650, § 870.3650 Pacemaker polymeric mesh bag, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89970
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ys:prov:89970@1- SHA-256
11824d93652d70dc1bab2454f2039009a59fba5ecd62d6c50dcdcf70653bc1b7
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Full text
(a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a pacemaker pulse generator. The bag is designed to create a stable implant environment for the pulse generator.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.