PMA P090022S028
- Device
- LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S028
- Product code
- HQL
- Decision date
- 2016-09-22
- Generic name
- intraocular lens
- Approval order statement
- Inclusion of one additional steam sterilizer unit for use in the sterilization of the IOLs.
Current openFDA PMA Record#
- Device
- LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S028
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2016-09-22
- Decision code
- OK30
- Date received
- 2016-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Inclusion of one additional steam sterilizer unit for use in the sterilization of the IOLs.