PMA P090022S035
- Device
- Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S035
- Product code
- HQL
- Decision date
- 2018-09-06
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Additional lens analyzer be added to the manufacturing process for the Softec HD, Softec HD PS, Softec I, Softec HDO, and Softec HDM IOLs.
Current openFDA PMA Record#
- Device
- Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S035
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2018-09-06
- Decision code
- OK30
- Date received
- 2018-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional lens analyzer be added to the manufacturing process for the Softec HD, Softec HD PS, Softec I, Softec HDO, and Softec HDM IOLs.