FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S004
·
Decision Jun 12, 1997
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- VISX EXCIMER LASER SYSTEM MODELS B AND C
- PMA Number
- P930016
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 12, 1997
- Date Received
- December 17, 1996
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Other
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR REVISED PROTOCOL FOR POST-APPROVAL STUDY TO DETECT AND REPORT RARE BUT SERIOUS ADVERSE EVENT. *PLEASE NOTE THAT LONG-TERM DATA MUST BE REFLECTED IN THE LABELING (VIA A SUPPLEMENT TO THE PMA) WHEN THE ADDITIONAL FOLLOW-UPS AND/OR POST-APPROVAL STUDIES ARE COMPLETED.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZS | Excimer Laser System | FDA class 3 | Unknown |