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 | VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S026 |
Date Received | 10/24/2006 |
Decision Date | 11/03/2006 |
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 UPGRADE OF THE WAVESCAN SOFTWARE TO VERSION 3.67 TO CORRECT A DESIGN FLAW THAT LED TO AN INCORRECT PATIENT TREATMENT BEING DELIVERED, AND TO INTRODUCE AN ADDITIONAL SOFTWARE CHECK TO MITIGATE TREATMENT CALCULATION ERRORS. |
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