Temporary freq range extension

0031-EX-PL-2003 Post Grant Documents

CardioMEMS, Inc.

2006-12-05ELS_78920

CardioMEMs Interrogator December 5, 2006 This request is for an extension to the experimental license to temporarily allow operation over the frequency band of 30-42MHz. FCC part 18 approval has already been granted for the CardioMEMs system that operates over 30-37.5MHz. Because our manufacturing process on the implanted heart failure sensor has not been finalized, a very few of our heart failure sensors will fall outside the approved 30-37.5MHz band. This is a temporary situation, but because our ability to manufacture the wireless heart failure sensor is limited, our ability to do clinical trials in heart failure would be hampered if we had to screen out the sensors that fell in the 37.5-42MHz range. The equipment current meets FCC part 18 emission requirements, and, as commonly used, will be turned on for only a few minutes a day, at the most, in a very limited number of hospitals across the U.S. Figure 1. This represents the CardioMEMs original clinical system approved for clinical trials under Form 442 confirmation number EL13012 and Form 442 file number 0031- EX-PL-2003

Figure 2. This represent the CardioMEMs version 1 system approved under FCC part 18. The documented frequency range of use is 30-37.5MHz. Figure 2. This represents the CardioMEMs version 2 system approved under FCC part 18. The documented frequency range is 30-37.5MHz, but CardioMEMs needs to operate this up to 42MHz for the U.S. clinical trails of the heart failure sensor.


Document Created: 2006-12-05 10:21:27
Document Modified: 2006-12-05 10:21:27
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