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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.
 
DeviceSTORZ MODULITH (TM) LITHOTRIPTER
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
1201 roberts blvd.
kennesaw, GA 30144
PMA NumberP920051
Supplement NumberS002
Date Received09/18/1995
Decision Date12/11/1995
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1)INCLUSION OF AN UPGRADED VIDEO MIXER; 2) MODIFICATION OF THE WATER CIRCUIT TO INCLUDE PRESSURE FEEDBACK; 3) REPLACEMENT OF THE NYLON/ALUMINUM PATIENT TABLE WITH A CARBON FIBER MODEL; 4) ADDITION OF THE FVP-30 X-RAY IMAGE PROCESSING FEATURE (WHICH ALSO INCLUDED REVISIONS OT THE X-RAY OPERATOR'S AND SERVICE MANUALS)
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