PMA P930016S059
- Device
- iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S059
- Product code
- LZS
- Decision date
- 2019-05-28
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S059
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2019-05-28
- Decision code
- APPR
- Date received
- 2019-03-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.