PMA P090022S009
- Device
- SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S009
- Product code
- HQL
- Decision date
- 2011-11-16
- Generic name
- intraocular lens
- Approval order statement
- APPROVAL FOR THE WAY IN WHICH A TEST REAGENT IS INCUBATED.
Current openFDA PMA Record#
- Device
- SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S009
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2011-11-16
- Decision code
- APPR
- Date received
- 2011-08-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE WAY IN WHICH A TEST REAGENT IS INCUBATED.