The Least Burdensome Provisions of the FDA Modernization Act of 1997, CDRH pdf

Study Design for Spinal Cord Stimulation (SCS) for Angina, Frank Lacy, CDRH pdf

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document

Working Group Neurocardiology Groningen (Clinical Organization) pdf

Clinical Assessment of Rate Adaptive Pacemakers, Megan Moynahan & Mitchell Shein, CDRH pdf

Medtronic Comments on Clinical Assessment of Rate-Adaptive Pacemakers pdf

Atrial Fibrillation Device Therapies, Stuart Portnoy, Marian Kroen, Dina Fleischer, Doris Terry, CDRH pdf