PMA P090022S039
- Device
- Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S039
- Product code
- HQL
- Decision date
- 2021-09-28
- Generic name
- intraocular lens
- Approval order statement
- Use of an alternate lens cleaner in the final cleaning process.
Current openFDA PMA Record#
- Device
- Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S039
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-09-28
- Decision code
- OK30
- Date received
- 2021-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternate lens cleaner in the final cleaning process.