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 | SUMMIT AUTONOMOUS LADARVISION 4000 SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S008 |
Date Received | 05/05/2000 |
Decision Date | 07/11/2000 |
Withdrawal Date
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05/15/2012 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CORRESPONDING COMPANY NAME CHANGE, DEVICE NAME CHANGE, AND SOME EXTERNAL CHANGES TO THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUMMIT AUTONOMOUS LADARVISION 4000 LASER SYSTEM. |
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