PMA P090022S026
- Device
- SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S026
- Product code
- HQL
- Decision date
- 2016-03-28
- Generic name
- intraocular lens
- Approval order statement
- Approval to reduce the center thickness of the currently approved Softec Model HD intraocular lens and assign it the new model designation Softec HDM intraocular lens.
Current openFDA PMA Record#
- Device
- SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S026
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2016-03-28
- Decision code
- APPR
- Date received
- 2015-12-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to reduce the center thickness of the currently approved Softec Model HD intraocular lens and assign it the new model designation Softec HDM intraocular lens.