870.3545 Ventricular bypass (assist) device.4. 21 CFR 870.3600 External pacemaker pulse generator.5. 21 CFR 870.3610 Implantable pacemaker pulse generator.6. 21 CFR 870.3680(b) Cardiovascular permanent pacemaker electrode.7. 21 CFR 870.3700 Pacemaker programmers.8. 21 CFR 870.3710 Pacemaker repair or replacement material.9. 21 CFR 870.4360 Nonroller-type cardiopulmonary bypass blood pump.10. 21 CFR 870.5200 External cardiac compressor.11. 21 CFR 870.5225 External counter-pulsating device.12. 21 CFR 870.5310 Automated external defibrillator.13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form).14. 21 CFR 872.3960 Mandibular condyle prosthesis (temporary implant).15. 21 CFR 876.5540(b)(1) Implanted blood access device.16. 21 CFR 876.5870 Sorbent hemoperfusion system.17. 21 CFR 882.5800 Cranial electrotherapy stimulator.18. 21 CFR 882.5940 Electroconvulsive therapy device.19. 21 CFR 884.5330 Female condom.20. 21 CFR 888.3070(b)(2) Pedicle screw spinal system (certain uses).21. 21 CFR 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses).24. 21 CFR 890.5525(b) Iontophoresis device (certain uses).25. 892.1990 Transilluminator for breast evaluation.Manufacturers of the above-listed devices must, by August 7, submit “a summary of, and citation to, any information known or otherwise available to them respecting the devices, including adverse safety and effectiveness data that has not been submitted under section 519 of the act” (e.g., medical device reports, reports of corrections and removals). Additional details respecting the format and content for such submissions can be found in FDA’s order.