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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP940008
Supplement NumberS006
Date Received07/25/1997
Decision Date08/13/1997
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
This supplement contains the changes to a document that was originally submitted with the investigational device exemption (ide) supplement application g950212/s8. The ide supplement requested to close the clinical investigation of res-q ii acd devices. Since the ide was officially closed, fda recommended to use this pma supplement as an administrative vehicle to address the dear doctor letter that was previously submitted as part of the ide supplement. Fda acknowledges that although the above information has been submitted as a supplement to this pma, the res-q ii acd is not part of the family of sulzer intermedics pma approved products. Fda further acknowledges that sulzer intermedics is not seeking commercial approval of the res-q ii acd device. Based upon the information submitted, the pma supplement is approved without conditions.