PMA P970043S009
- Device
- LADARVISION EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories
- PMA number
- P970043
- Supplement
- S009
- Product code
- LZS
- Decision date
- 2000-08-28
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR REDUCING BY 20% THE ABLATION DEPTH VALUES THAT ARE PROVIDED IN THE PHYSICIAN BOOKLET AND DISPLAYED BY THE DEVICE.
Current openFDA PMA Record#
- Device
- LADARVISION EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories
- PMA number
- P970043
- Supplement
- S009
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2000-08-28
- Decision code
- APPR
- Date received
- 2000-08-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REDUCING BY 20% THE ABLATION DEPTH VALUES THAT ARE PROVIDED IN THE PHYSICIAN BOOKLET AND DISPLAYED BY THE DEVICE.