PMA P090022S027

Device
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S027
Product code
HQL
Decision date
2016-02-12
Generic name
intraocular lens
Approval order statement
Installation of an additional steam sterilizer.

Current openFDA PMA Record#

Device
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S027
Product code
HQL
Generic name
intraocular lens
Decision date
2016-02-12
Decision code
OK30
Date received
2016-01-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Installation of an additional steam sterilizer.