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 | STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S018 |
Date Received | 12/15/2003 |
Decision Date | 06/07/2004 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR SOFTWARE UPGRADE: WAVESCAN SOFTWARE VERSION 3.5 CHANGES FROM CURRENTLY APPROVED VERSION 3.07 (UNDER P930016/S016) FOR VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM FOR WAVEFRONT-GUIDED LASIK TREATMENTS OF MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D. |
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