RE: Iodine Seed Implants

[Craig Reed <CReed@novoste.com>]

Depending upon the desired indications for use, you don't need an IDE
for such a 510(k) device so a study to demonstrate tr.


-----Original Message-----
From: Chris Alston [mailto:alstonc@odrge.odr.georgetown.edu]
Sent: Wednesday, December 15, 1999 6:16 PM
To: Multiple recipients of list
Subject: Iodine Seed Implants


Does anyone know of actual studies of patients who'd received permanent
implants, to document that the seeds did not leak? I mean, either in
vivo
thyroid monitoring, or urine collection, within the first few
half-lives. I
would have thought that some such work would have been a part of the
original Phase 1 IDE, but maybe the FDA thought that it was sufficient
to
demonstrate their extracorporeal integrity, and presume that the same
would
obtain post-implantation. Also, maybe some early users thought it the
better part of valor, or worth a decent paper, to do the studies.

Thanks, again, in advance.

cja

P.S. Does anyone know where I might find one or more HP10/11/15C
calculators, hopefully in at least VG condition? Of course, please
respond
to me directly, not to the list. Thanks much.
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