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. |
|
Device | ALCON LADARVISION 4000 EXCIMER LASER SYSTEM- |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S021 |
Date Received | 09/26/2005 |
Decision Date | 10/14/2005 |
Withdrawal Date
|
05/15/2012 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SOFTWARE CALIBRATION "LOCK-OUT" FEATURE WHERBY THE LASER SYSTEM WILL BE "LOCKED-OUT" TO PREVENT THE INITIATION OF SURGERY MORE THAN 60 MINUTES AFTER THE LAST SYSTEM CALIBRATION, A "COUNTDOWN CLOCK" ON THE COMPUTER MONITOR WHICH WILL PROVIDE THE USER WITH FEEDBACK ON THE REMAINING TIME BEFORE THE SYSTEM WILL LOCK-OUT, AND A SOFTWARE BUG FIX TO CORRECT A CERTAIN "BUG" FROM OCCURRING UNDER CERTAIN CONDITIONS IF THE RULER TOOL WAS USED WITH THE TRACKER ENGAGED DURING SURGERY. |
|
|