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 | S002 |
Date Received | 05/16/1996 |
Decision Date | 11/07/1996 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR: 1)A PROTOCOL FOR A PROSPECTIVE POSTAPPROVAL STUDY TO DETECT RARE BUT SERIOUS ADVERSE EVENTS; AND, 2)CHANGES TO UPDATE YOUR PHASE III PRK PROTOCOL FOR POSTAPPROVAL FOLLOW-UP PURPOSES. FDA ACKNOWLEDGES THAT SUPPLEMENT 1 (APPROVED ON 15-OCT-96) NEGATES THE NEED FOR A CONTRAST SENSITIVITY/GLARE STUDY OR PROTOCOL. PLEASE NOTE THAT LONG-TERM DATA MUST BE REFLECTED IN THE LABELING (VIA A SUPPLEMENT TO THE PMA) WHEN THE ADD'L FOLLOW-UPS AND/OR POSTAPPROVAL STUDIES ARE COMPLETED |
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