PMA P090022S014

Device
LENSTEC SOFTEC HD PCIOL
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S014
Product code
HQL
Decision date
2012-09-20
Generic name
intraocular lens
Approval order statement
INCLUSION OF TWO ADDITIONAL STEAM STERILIZER UNITS FOR THE STERILIZATION OF THE FIRM'S SOFTEC SERIES OF IOLS.

Current openFDA PMA Record#

Device
LENSTEC SOFTEC HD PCIOL
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S014
Product code
HQL
Generic name
intraocular lens
Decision date
2012-09-20
Decision code
OK30
Date received
2012-08-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
INCLUSION OF TWO ADDITIONAL STEAM STERILIZER UNITS FOR THE STERILIZATION OF THE FIRM'S SOFTEC SERIES OF IOLS.