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 | SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK) |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 2501 DISCOVERY DRIVE,SUITE 500 ORLANDO, FL 32826-3714 |
PMA Number | P930034 |
Supplement Number | S001 |
Date Received | 12/26/1995 |
Decision Date | 02/05/1997 |
Withdrawal Date
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05/18/2010 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO USE LASER VISION CORRECTION OR LVC AS A SYNONYM FOR PHOTOREFRACTIVE KERATECTOMY OR PRK IN YOUR LABELING. THE APPLICATION IS APPROVED SUBJECT TO THE CONDITION THAT LVC WILL NOT BE USED IN THE FOLLOWING INSTANCES: 1)IN ADS TO PRACTITIONERS; 2)IN SECTION THAT CONTAIN THE APPROVED INDICATION, CONTRAINDICATION, WARNING, PRECAUTION, CAUTION, AND "A-J" STATEMENTS IN THE FDA APPROVAL ORDER DATED OCTOBER 20, 1995; 3) ON THE TITLE PAGE OF THE PATIENT INFORMATION BOOKLET; 4) AT THE BEGINNING OF TEXT IN A BOOKLET OR AN AD, UNTIL THE TERM "LASER VISION CORRECTION (LVC)" IS DEFINED AS A REPLACEMENT FOR PRK; AND 5) WHEN DISTINGUISHING THE VARIOUS SURGERIES, E.G., PTK AND PRK (NOT LVC). |
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