PMA P090022S020

Device
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S020
Product code
HQL
Decision date
2014-06-16
Generic name
intraocular lens
Approval order statement
APPROVAL TO ALLOW FOR THE DISTRIBUTION OF AN ALTERNATE PACKAGING OF THE PRE-LOADED INJECTOR (PLI) TIPS IN A 12-PACK CARTON.

Current openFDA PMA Record#

Device
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S020
Product code
HQL
Generic name
intraocular lens
Decision date
2014-06-16
Decision code
APPR
Date received
2014-03-18
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL TO ALLOW FOR THE DISTRIBUTION OF AN ALTERNATE PACKAGING OF THE PRE-LOADED INJECTOR (PLI) TIPS IN A 12-PACK CARTON.