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. |
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Device | LADARVISION EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S001 |
Date Received | 01/28/1999 |
Decision Date | 09/24/1999 |
Withdrawal Date
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05/15/2012 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the inclusion of labeling claims in the Patient Information Booklet, Physician's Booklet, and System Operation Manual regarding the effectiveness of the eye tracker component of the LADARVision(R) Excimer Laser System when used for the approved indication. Other requested modifications to the labeling included updates to data tables in the Physician's Booklet, and editorial changes and revised operational procedures in the System Operation Manual. |
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