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 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S032 |
Date Received | 09/18/2009 |
Decision Date | 03/09/2010 |
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 |
Approval Order Statement APPROVAL FOR SOFTWARE VERSION 4.70 (STAR S4) AND VERSION 5.30 (STAR S4 IR). |
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