PMA P090022S023
- Device
- THE SOFTEC HD IOL
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S023
- Product code
- HQL
- Decision date
- 2014-07-09
- Generic name
- intraocular lens
- Approval order statement
- ADD THREE COMPONENT WASHERS FOR THE USE IN THE FINAL CLEAN AREA AND INSPECTION DEPARTMENT TO REDUCE BIOBURDEN AND ENDOTOXIN OF THE INTRAOCULAR LENSES.
Current openFDA PMA Record#
- Device
- THE SOFTEC HD IOL
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S023
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2014-07-09
- Decision code
- OK30
- Date received
- 2014-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD THREE COMPONENT WASHERS FOR THE USE IN THE FINAL CLEAN AREA AND INSPECTION DEPARTMENT TO REDUCE BIOBURDEN AND ENDOTOXIN OF THE INTRAOCULAR LENSES.