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 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P910062 |
Supplement Number | S008 |
Date Received | 12/31/2018 |
Decision Date | 04/12/2019 |
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 four edits in engineering drawing of "Beam Splitter, Energy Detector'' and change of the material in the Beam Splitter component of the Energy Detector from Corning Fused Silica Code 7940 to Corning 7980 HPFS. |
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