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Re: [IP] FDA Approves new Animas Insulin Pump



Has anyone heard if the Animas IR1250 has addressed the readability issue? 
I sent the IR1200 back because the backlight was not strong enough for me.
Are they going back to the 300 cartridge?
Shirley
----- Original Message ----- 
From: "Artorius Rex" <email @ redacted>
To: <email @ redacted>
Sent: Thursday, January 06, 2005 5:54 PM
Subject: 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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