Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
Generic NameSYSTEM, IMAGING, FLUORESCENCE
ApplicantNovadaq Technologies, Inc.
2585 Skymark Ave., Suite 306
Mississauga, Ontario L4W 4L5
PMA NumberP950042
Supplement NumberS004
Date Received07/18/2007
Decision Date09/05/2007
Product Code MRK 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A TRADE NAME CHANGE FROM ONCO-LIFE TO PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA.
-
-