PMA P930034S001

Device: SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S001
Product code: LZS
Decision date: 1997-02-05
Generic name: Excimer laser system
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).

Current openFDA PMA Record

Device: SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S001
Product code: LZS
Generic name: Excimer laser system
Decision date: 1997-02-05
Decision code: APPR
Date received: 1995-12-26
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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).