PMA P090022S034

Device
Lenstec Softec HD aspheric posterior chamber intraocular lens
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S034
Product code
HQL
Decision date
2017-06-05
Generic name
intraocular lens
Approval order statement
Supplier change for the glass vials and lids used to package the Softec Intraocular Lenses.

Current openFDA PMA Record#

Device
Lenstec Softec HD aspheric posterior chamber intraocular lens
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S034
Product code
HQL
Generic name
intraocular lens
Decision date
2017-06-05
Decision code
OK30
Date received
2017-05-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Supplier change for the glass vials and lids used to package the Softec Intraocular Lenses.