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 FOR PHOTOREFRACTIVE KERATECTOMY (PRK) |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S008 |
Date Received | 09/15/1998 |
Decision Date | 02/23/1999 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to consider report of the postapproval studies a final report and to discontinue all PRK postapproval study requirements. The Model C(STAR) device, as modified in supplement 7, will be marketed under the trade name VISX STAR S2 Excimer Laser System and is indicated for the treatment of myopia, astigmatism and hyperopia (sphere only). |
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