• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
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).