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 EXCIMER LASER SYSTEM MODELS B AND C |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S003 |
Date Received | 08/26/1996 |
Decision Date | 04/24/1997 |
Product Code |
LZS |
Docket Number | 97M-0084 |
Notice Date | 04/17/1998 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE VISX EXCIMER LASER SYSTEM (MODELS B & C). THIS DEVICE IS INDICATED FOR MYOPIC ASTIGMATIC PHOTOREFRACTIVE KERATECTOMY (PRKA) USING AN ABLATION ZONE WITH A 6.0 MM MAJOR AXIS |
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