PMA P930016S038
- Device
- WAVESCAN WAVEFRONT SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S038
- Product code
- LZS
- Decision date
- 2013-06-27
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR CHANGES TO THE WAVESCAN WAVEFRONT SYSTEM DEVICE LABELING (USER MANUAL).
Current openFDA PMA Record#
- Device
- WAVESCAN WAVEFRONT SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S038
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2013-06-27
- Decision code
- APPR
- Date received
- 2013-05-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE WAVESCAN WAVEFRONT SYSTEM DEVICE LABELING (USER MANUAL).