PMA P090022S037
- Device
- Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S037
- Product code
- HQL
- Decision date
- 2020-10-23
- Generic name
- intraocular lens
- Approval order statement
- Qualifying the addition of a prewash step to the manufacturing process for vials used to package its intraocular lenses (IOLs).
Current openFDA PMA Record#
- Device
- Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S037
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-10-23
- Decision code
- OK30
- Date received
- 2020-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualifying the addition of a prewash step to the manufacturing process for vials used to package its intraocular lenses (IOLs).