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 PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 2501 DISCOVERY DRIVE,SUITE 500 ORLANDO, FL 32826-3714 |
PMA Number | P930034 |
Supplement Number | S012 |
Date Received | 07/14/1998 |
Decision Date | 10/21/1999 |
Withdrawal Date
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05/18/2010 |
Product Code |
LZS |
Docket Number | 00M-0424 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the SVS Apex Plus Excimer Laser Workstation, emphasis(R) discs K and L, and axicon. These devices are indicated to perform hyperopic PRK. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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