• 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.
 
DeviceALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP020050
Supplement NumberS008
Date Received07/30/2012
Decision Date09/07/2012
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR INTRODUCTION OF A NEW NOTEBOOK COMPUTER MODEL(TOSHIBA TECRA A11) TO REPLACE THE CURRENT NOTEBOOK MODEL (TOSHIBA TECRA M10) WHICH IS BEING PHASED OUT BY THE MANUFACTURER. THIS WILL REQUIRE A CHANGE IN THE OPERATING SYSTEM FROM WINDOWS 2000 TO WINDOWS XP SERVICE PACK 2 AS THE NEW NOTEBOOK COMPUTER WILL NOT BESUPPORTED BY THE OLD SYSTEM.
-
-