FYI-Regarding "Swedish" Band
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Just for your info, I inquired about the Swedish version at the FDA and here is the response:
This is in response to your email below to the food and Drug
Administration
(FDA) requesting information on the "Swedish Lap Band."
If a device is under the FDA's review, it would be considered
confidential
and we are prohibited, by law, from releasing information on it. Only
once
a device has final FDA approval can we release information to the
public.
The manufacturer, however, is at liberty to release information on a
pending
device, should they choose to, therefore you may want to contact them
directly for information.
Currently, there is not a device with the model name "Swedish Lap Band"
approved by the FDA, however, in June 2001 the FDA approved the Lap
Band
Adjustable Gastric Banding System manufactured by Bioenterics
Corporation.
For all information on the approval of this device, please visit our
web
site at:
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01087.html
http://www.fda.gov/cdrh/mda/docs/p000008.html
http://www.fda.gov/cdrh/pdf/p000008.html
I hope this information is helpful.
Sincerely,
Bonnie J. Alderton
Consumer Staff
Division of Small Manufacturers,
International and Consumer Assistance
Center for Devices and Radiological Health
bonnie.alderton@fda.hhs.gov