PMA P150040S007
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S007
- Product code
- OTL
- Decision date
- 2020-11-23
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- Additional suppliers for blister packaging which is a part of primary package for the Treatment Pack.
Current openFDA PMA Record#
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S007
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2020-11-23
- Decision code
- OK30
- Date received
- 2020-10-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional suppliers for blister packaging which is a part of primary package for the Treatment Pack.