1700800388
1700800389
§870.3300-Vascular embolization device.
1700800390
1700800391
§870.3375-Cardiovascular intravascular filter.
1700800392
1700800393
§870.3450-Vascular graft prosthesis.
1700800394
1700800395
§870.3470-Intracardiac patch or pledget made of polypropylene，polyethylene terephthalate，or polytetrafluoroethylene.
1700800396
1700800397
§870.3535-Intra-aortic balloon and control system
1700800398
1700800399
§870.3545-Ventricular bypass（assist）device.
1700800400
1700800401
§870.3600-External pacemaker pulse generator.
1700800402
1700800403
§870.3610-Implantable pacemaker pulse generator.
1700800404
1700800405
§870.3620-Pacemaker lead adaptor.
1700800406
1700800407
§870.3630-Pacemaker generator function analyzer.
1700800408
1700800409
§870.3640-Indirect pacemaker generator function analyzer.
1700800410
1700800411
§870.3650-Pacemaker polymeric mesh bag.
1700800412
1700800413
§870.3670-Pacemaker charger.
1700800414
1700800415
§870.3680-Cardiovascular permanent or temporary pacemaker electrode.
1700800416
1700800417
§870.3690-Pacemaker test magnet.
1700800418
1700800419
§870.3700-Pacemaker programmers.
1700800420
1700800421
§870.3710-Pacemaker repair or replacement material.
1700800422
1700800423
§870.3720-Pacemaker electrode function tester.
1700800424
1700800425
§870.3730-Pacemaker service tools.
1700800426
1700800427
§870.3800-Annuloplasty ring.
1700800428
1700800429
§870.3850-Carotid sinus nerve stimulator.
1700800430
1700800431
§870.3925-Replacement heart valve.
1700800432
1700800433
§870.3935-Prosthetic heart valve holder.
1700800434
1700800435
§870.3945-Prosthetic heart valve sizer.
1700800436
1700800437
以上的每个类型，FDA都给出了监管程度分类。比如870.3610-Implantable pacemaker pulse generator（植入式心脏起搏器），其监管分类为第三类（Class Ⅲ），即最严格的监管类别。数以万计的医疗器材和诊断试剂就按照这样的体系分类完毕，每一种器械都按照分类遵守相应程度的监管。
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