SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS
FDA premarket approval P930034/S012 · decided 1999-10-21
Approval details
- PMA number
- P930034
- Supplement
- S012
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1998-07-14
- Decision date
- 1999-10-21
- Days to decision
- 464 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Orlando, FL
- Statement
- Approval for the SVS Apex Plus Excimer Laser Workstation, emphasis(R) discs K and L, and axicon. These devices are indicated to perform hyperopic PRK.
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