PMA P090022S008
- Device
- SOFTEC HD INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S008
- Product code
- HQL
- Decision date
- 2011-09-28
- Generic name
- intraocular lens
- Approval order statement
- REMOVAL OF TWO MANUFACTURING PROCESS STEPS IN ORDER TO MAKE THE IOL MANUFACTURING PROCESS MORE EFFICIENT.
Current openFDA PMA Record#
- Device
- SOFTEC HD INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S008
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2011-09-28
- Decision code
- OK30
- Date received
- 2011-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF TWO MANUFACTURING PROCESS STEPS IN ORDER TO MAKE THE IOL MANUFACTURING PROCESS MORE EFFICIENT.