PMA P090022S047
- Device
- Softec HD; Softec I; Softec HDO; Softec HDM
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S047
- Product code
- HQL
- Decision date
- 2025-12-04
- Classification
- Ophthalmic
- Generic name
- intraocular lens
- Approval order statement
- approval for a different material vial stopper from an alternate supplier.
Current openFDA PMA Record#
- Device
- Softec HD; Softec I; Softec HDO; Softec HDM
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S047
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2025-12-04
- Decision code
- APPR
- Date received
- 2025-09-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a different material vial stopper from an alternate supplier.