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 | VisuMax & VISUMAX 800 |
Generic Name | Femtosecond laser system for refractive correction |
Applicant | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
PMA Number | P150040 |
Supplement Number | S015 |
Date Received | 02/20/2024 |
Decision Date | 03/18/2024 |
Product Code |
OTL |
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 the addition of a Treatment Pack clear tubing supplier |
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