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 EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P910062 |
Supplement Number | S006 |
Date Received | 05/19/2014 |
Decision Date | 05/30/2014 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A RE-POLISHING PROCESS FOR THE HEX PRISM ASSEMBLY, OF THE STAR SYSTEM. |
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