SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
FDA premarket approval P930034/S001 · decided 1997-02-05
Approval details
- PMA number
- P930034
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1995-12-26
- Decision date
- 1997-02-05
- Days to decision
- 407 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Orlando, FL
- 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
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