PMA P090022S018
- Device
- SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S018
- Product code
- HQL
- Decision date
- 2013-07-03
- Generic name
- intraocular lens
- Approval order statement
- INCLUSION OF THREE ADDITIONAL STEAM STERILIZER UNITS.
Current openFDA PMA Record#
- Device
- SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.
- Applicant
- Lenstec, Inc.
- PMA number
- P090022
- Supplement
- S018
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2013-07-03
- Decision code
- OK30
- Date received
- 2013-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INCLUSION OF THREE ADDITIONAL STEAM STERILIZER UNITS.