Greg, I downloaded the FDA's annual report from the link you provided and it confirms the rumour that the FDA has designated the FAST1 as a "significant medical device breakthrough".
For those who can't read files in PDF format, here's an extract of the text of interest to us - bolding is mine.
P.S. for Dani - note that Pyng's submission for the FAST1 is also on the FDA site.
=============
OFFICE OF DEVICE EVALUATION
ANNUAL REPORT
FISCAL YEAR 1997
(October 1, 1996 - September 30, 1997)
U.S. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health
[snip]
FY 97 ODE Annual Report APPENDIX B [page 30]
APPENDIX B. SIGNIFICANT MEDICAL DEVICE BREAKTHROUGHS Fiscal Year 1997
The following devices were approved via PMAs, PMA Supplements, and HDEs or cleared via 510(k)s during FY97. They represent significant medical breakthroughs because they are first-of-a kind, e.g., they use a new technology or energy source, or they provide a major diagnostic or therapeutic advancement, such as reducing hospital stays, replacing the need for surgical intervention, reducing the time needed for a diagnostic determination, etc. The information for each device includes the trade name and/or classification name, firm, PMA /510(k) number and date of approval.
[snip]
DDIGD F.A.S.T.1 Intraosseous Infusion System by Pyng Medical Corp. (K970380, April 25, 1997) |
