FDA, Center Devices, Orthopaedic Panel Mtg 11/14/08

[Slackwater]

Link

Food and Drug Administration (FDA) meeting open to the public.

Name of Committee Orthopaedic and Rehabilitation Devices Panel
Date and Time Nov 14, 08 8:00 AM - 5:00 PM

The agenda is on

ReGen is requesting clearance of the ReGen Collagen Scaffold (CS) for the meniscus in the knee, I believe.

Net Result:

Not on Artificial Discs (ADR, TDR, TDA)

RenGen makes a Collagen Scaffold for the knee, like other soft-tissue scaffolds before it, is a precursor to scaffolds for the intervertebral disc. It will be interesting to see the result.

I was disappointed about the last CDRH meeting on Oxiplex that reduces adhesions in microdiscectomies, so ...

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Slackwater_SF

[kimmers]

So Slackwater where are these meetings held?

I heard a little bit about this treatment.
I have a church friend who has a torn up knee and I think she was telling me about the treatment and how her insurance denied it.

At least that is what I remember.
Thanks for the posting, Slack.

Kimmers

[Slackwater]

Originally Posted by kimmers

So Slackwater where are these meetings held?

Kimmers

Suggest the meetings are held close to FDA central (?), CDRH team, which is between Gaithersburg, MD and Silver Springs, MD (?) among other places, guessing, from the locations of available job openings.

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Location

Hilton Washington DC North/Gaithersburg, Salons A, B, and C
620 Perry Pkwy.
Gaithersburg , MD

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CDRH = Center For Device and Radiological Health, the team that evaluates ADR TDR TDA IVD devices. They had Oxiplex for review and the above tissue scaffold apparently is also a device.


Slackwater_SF