PMA P090022S025
- Device
- SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S025
- Product code
- HQL
- Decision date
- 2016-10-20
- Generic name
- intraocular lens
- Approval order statement
- Approval of a new raw material production method for the device molding.
Current openFDA PMA Record#
- Device
- SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S025
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2016-10-20
- Decision code
- APPR
- Date received
- 2015-09-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of a new raw material production method for the device molding.