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Re: [IP] FDA Approves new Animas Insulin Pump



Fantastic!

Here's a summary of what they changed:

"Comparison of the Technological Features of the Modified Device
and the Predicate Device: The modified device and the predicate
device are identical in terms of design, materials, and construction. The
only change made to the IR1200 is increased storage capability, in pump
memory, and the minor software modifications which allow the IR1250
pump to receive program instructions from a PC, with ezManager Plus
software, and accept into pump storage approximately 500 food items
with associated carbohydrate information. This information can be
referenced, at any time, on the pump screen, for evaluating insulin needs."

I'm glad they followed through on their promise to increase the cartridge
capacity.   I think that's what "increased storage capability" means.

-Brent


--- email @ redacted wrote:

> http://www.fda.gov/cdrh/510k/sumdec04.html
> 
> "DEVICE: ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
> ANIMAS CORP.                      510(k) NO: K042873(TRADITIONAL)
> ATTN: THOMAS L PARKER             PHONE NO : 484-568-1257
> 200 LAWRENCE DR.                  SE DECISION MADE: 10-DEC-04
> WEST CHESTER, PA 19380            510(k) SUMMARY AVAILABLE FROM FDA"
> .
> ----------------------------------------------------------
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