PMA P090022S024
- Device
- SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S024
- Product code
- HQL
- Decision date
- 2015-01-15
- Generic name
- intraocular lens
- Approval order statement
- NOTIFICATION OF AN ADDITIONAL ROTLEX IOLA PLUS LENS ANALYZER USED DURING THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S024
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2015-01-15
- Decision code
- OK30
- Date received
- 2014-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NOTIFICATION OF AN ADDITIONAL ROTLEX IOLA PLUS LENS ANALYZER USED DURING THE MANUFACTURING PROCESS.