SVS APEX PLUS EXCIMER LASER WORKSTATION
FDA premarket approval P930034/S013 · decided 1999-10-21
Approval details
- PMA number
- P930034
- Supplement
- S013
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SVS APEX PLUS EXCIMER LASER WORKSTATION
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1999-02-11
- Decision date
- 1999-10-21
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Orlando, FL
- Statement
- APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS(R) "M" DISCS (M00-M09) THESE DEVICES ARE INDICATED TO PERFORM LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM 0.0 TO -14.0 DIOPTERS (D) WITH OR WITHOUT ASTIGMATISM RANGING FROM -0.5D TO -5.0D; 2) IN PATIENTS 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION (+0.5D) OVER THE PAST YEAR.
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