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 | SVS APEX APEX EXIMER LASER WORKSTATION |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 2501 DISCOVERY DRIVE,SUITE 500 ORLANDO, FL 32826-3714 |
PMA Number | P930034 |
Supplement Number | S007 |
Date Received | 11/20/1996 |
Decision Date | 03/12/1997 |
Withdrawal Date
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05/18/2010 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW LASER CALIBRATION MEDIUM AND PROCEDURE. |
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