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 | S001 |
Date Received | 04/18/1996 |
Decision Date | 10/15/1996 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement LABELING CHANGES (I.E., MINOR EDITORAL CHANGES TO THE PATIENT INFORMATION BOOKLET, CONTRAST SENSITIVITY/GLARE PRECAUTIONARY STATEMENT IN LIEU OF A POSTAPPROVAL CONTRAST SENSITIVITY STUDY, AND DEFINITIONS OF POTENTIAL RISKS WITH PRK) |
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