Let's see what the advi{*filter*}t I recieved from you really was.
And while were at it let's see what your "specialist" replied to about
the Christenson Implant. See both below.
No Regards,
BC
|>As you were clearly advised some days ago (September 7), Bruce, the
|>specific wording of the database entry in question was appropriately
|>revised on September 5 in response to the original post from Sabra Broock
|>concern in the matter are certainly appreciated.
|>John D. Buquoi
|>www.onlinedoc.com
Date: Fri, 6 Sep 1996 21:37:12 -0600
Subject: Your Posts to sci.med.dentistry re: Doc In The Box
X-UIDL: 842063808.000
Bruce,
Just a note to hopefully wrap up all the "fun" that you, your
organization and your associates have had at the expense of
www.onlinedoc.com.
We can probably agree that you and Ms. Broock (also a cts.com
account...hmmmm!) found and pointed out what was a materially
insignificant mis-statement in the database at the subject site. While
you could have directly contacted the site to point out the error, you
elected to go public with it at sci.med.dentistry. You even threatened
an FDA complaint when you knew that the facts won't support one. No
problem, your right...your choice.
As soon as the mis-statement was brought to our attention, the
database was modified to accommodate your objections. You were so
advised.
I think at this point, however, it's important to point out to you,
the company that you represent, and the service providers
(NNTP-Posting-Host: changjin.cts.com) who provide your connectivity
that your postings and re-postings of rants alleging "spreading lies"
and "this bold faced attempt to defraud the public", "it's someone
taking advantage of what the public doesn't know or understand",
"truly the strangest lie I have seen lately", and "someone is
promoting a device" all fall within the clear legal definition of
defamation and libel.
There was no "lie", no "attempt to defraud", no "taking advantage",
again no "strangest lie" and "no promoting a device". You certainly
know all that. You may not be aware that such outrageous publication
of libellous material through the usegroups is not excused under the
law, and is actionable under civil statutes. I want you to be aware of
that...
I would also be amazed if such outrageous postings as you have made to
the usegroup in this matter don't constitute a gross breach of the
Acceptable Use Guidelines to which cts.com might expect user
adherence. I know that they are in breach of the FAQs on usegroups.
I am not so naive as to assume that your daily pious posturings,
hysteria and sanctimonious buffoonery in this matter are not without
an (as yet) unidentified measure of self-interest. Please accept this
post in the spirit in which it is intended...as a clear caution to you
and your sense of self-interest that you should cease and desist from
publishing or promoting further defamation and libel against
www.onlinedoc.com, Doc In The Box and the Board Certified
Professionals associated with that site, at risk of legal action which
could involve both you and your service providers.
Thank you for your cooperation.
John D. Buquoi
.
John D. Buquoi
InterWeb Business Development Group
12011 Audelia, Suite B-103
Dallas, TX 75243
(214) 348-1675
www.ibdg.com
Date: Fri, 6 Sep 1996 08:12:25 -0500 (CDT)
Subject: TMJ prosthesis
X-UIDL: 842018850.002
Subject: TMJ prosthesis
Dear Rob,
The TMJ Fossa-Eminence and TMJ Condylar Prostheses manufactured by TMJ
Implants, Inc. (the "Company"), are legally marketed in compliance
with the Federal Food, Drug, and Cosmetic Act ("FDC Act") for use in
the partial and total reconstruction of temporomandibular joint
disorders.
The Fossa-Eminence and condylar Prostheses have been in commercial
distribution in the United States in their present form for both
partial and total TMJ reconstruction since prior to May 28, 1976, the
enactment date of the 1976 Medical Device Amendments to the FDC Act.
The prostheses have been used both individually (Fossa-Eminence or
Condylar) as a partial TMJ prosthesis and together (Fossa-Eminence and
Condyle) as a total TMJ prosthesis siince their introduction in 1961
and 1965, respectively. As "preamendment" devices, the prostheses are
exempt from the premarket notificaation requirements under section
510(k) of the FDC Act. Accordingly, as long as the Fossa-Eminence and
Condylar Prostheses are not significantly changed or modified in any
fashion they can continue to be legally marketed without prior FDA
premarket clearance or approval.
The Preamendment status of the company's prostheses for partial and
total TMJ reconstruction was confirmed by the cooking.net">food and Drug
Administration ("FDA") in 1992 in response to the company's request
for such determination. The letter states:
Quote:
> We (FDA) have determined that the records and affidavits which you
> (TMJ Implants, Inc.) have submitted for our review are sufficient
> to support the preamendment status for the Fossa-Eminence and
> Condylar Prostheses. Premarket notification would not be required
> for these devices to continue to be marketed, providing they were the
> same devices, with the same intended use, manufactured according to
> the processes as those used on or before May 28, 1976.
The above letter is from Ronald M. Johnson, Director, Office of
Compliance and Surveillance, Center for Devices and Radiological
Health, to Dr. Robert Christensen, President, TMJ Implants, Inc. (Dec.
2, 1992)
In addition, the company submitted and obtained FDA marketing
clearance of two separate 510(k) notifications for the Fossa-Eminence
and condylar Prostheses on October 25, 1993 and April 21, 1994,
respectively for sterile versions of the devices.
The 510(k) notification "clearance" procedure allows FDA to find that
a medical device is substantially equivalent to a legally marketed
predicate device. This determination results in a classification of
the device and permits the device to be legally marketed in the same
manner as the predicate device. "Clearance" of a 510(k) notification
does not mean that the FDA "approves" the device on the basis of
clinical evidence of safety and effectiveness. In the case of the
sterile Fossa-Eminence and Condylar Prostheses, FDA determined that
these devices were substantially equivalent to the non-sterile devices
that were in commercial distribution prior to the enactment of the
Medical Device Amendments of 1976, and, therefore, could be
legally marketed in the United States.
Finally, FDA has issued a proposed rule to classify certain TMJ
implants as class III medical devices and require submission of
premarket approval ("PMA") appplications for such devices. However,
submission of PMA applications cannot be required by FDA prior to 30
months following issuance of a final classification regulation. Until
such time, the Fossa-Eminence and Condylar Prostheses can be legally
marketed in full compliance with the FDC Act.
In summary, when distributed as non-sterile or sterile devices, the
Fossa-Eminence and condylar Prostheses are legally marketed in full
compliance with the FDC Act for use in partial or total reconstruction
of TMJ disorders. For further information the FAX # of TMJ Implants,
Inc. is 303-277-1421.
Quote:
>--------------------------------------------------------------------------
As to the "approval" of these prostheses by the FDA, they are
certainly approved for marketing and distribution in full compliance
with FDA and FDC regulations. They are indeed different than the
total joint prostheses that were marketed and distributed by the Vitek
Company, and all of us as {*filter*}& Maxillo{*filter*} Surgeons will be forced
to live the rest of our practice careers with that unfortunate legacy.
TMJ device FDA approval was: Doc in the Box database re: Total TMJ device