• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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.
 
Trade NameXILLIX-LIFE-LUNG
Classification Namesystem, imaging, fluorescence
Generic Namefluorescence imaging system
ApplicantHOGAN & HARTSON
PMA NumberP950042
Supplement NumberS001
Date Received04/30/1998
Decision Date07/21/1998
Product Code
MRK[ Registered Establishments with MRK ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to amend the post-market study. A third investigator will be added to assist in collecting sets of images whichwill be used to produce the "test set" of images for the reproducibility testing.
-
-