PMA P930016S050
- Device
- iDesign Advanced WaveScan Studio
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S050
- Product code
- LZS
- Decision date
- 2017-04-05
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Manufacturing improvements to the iDesign Advanced WaveScan Studio fixation target.
Current openFDA PMA Record#
- Device
- iDesign Advanced WaveScan Studio
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S050
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2017-04-05
- Decision code
- OK30
- Date received
- 2017-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing improvements to the iDesign Advanced WaveScan Studio fixation target.