{"data":{"id":"us/21-cfr-870.3650","jurisdiction":"us","citation":"21 CFR 870.3650","heading":"Pacemaker polymeric mesh bag.","body":"(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.\n(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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"f735e773a0987ac20fbb61b270def19c722d224397030c5358b1e9787228d737","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.3640","next":"us/21-cfr-870.3670"},"notice":"GroundRules: Original legal text. Not legal advice."}