PMA P090022S013
- Device
- SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S013
- Product code
- HQL
- Decision date
- 2012-08-16
- Generic name
- intraocular lens
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING THAT ENHANCES THE SAFETY IN THE USE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S013
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2012-08-16
- Decision code
- APPR
- Date received
- 2012-07-24
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING THAT ENHANCES THE SAFETY IN THE USE OF THE DEVICE.