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 |
Generic Name | Excimer laser system |
Applicant | ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TX 76134 |
PMA Number | P910067 |
Supplement Number | S003 |
Date Received | 05/21/1998 |
Decision Date | 06/04/1998 |
Withdrawal Date
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05/18/2010 |
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 an external chiller option for the SVS Apex Plus Excimer Laser System. |
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