 Additional Site Location Form 19May09 |
 Device Supplemental Submission Form 19May09 |
 Emergency Use Form 21May09 |
 Informed Consent Documentation Waiver Form 19May09 |
 Initial Protocol Submission Form 19May09 |
 Request for Exemption Determination 19May09 |
 Site Submission Form 22Oct09 |
 Waiver of HIPPA documentation Form 19May09 |