PMA P970034S006

Device
POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant
Aaren Scientific
PMA number
P970034
Supplement
S006
Product code
HQL
Decision date
2000-08-31
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
APPROVAL TO EXTEND THE POWER RANGE FOR YOUR LENSES TO INCLUDE POWERS BETWEEN +3.5 AND -12.0 DIOPTERS (EXCLUDING ZERO DIOPTER) IN 0.5 DIOPTER INCREMENTS.

Current openFDA PMA Record#

Device
POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant
Aaren Scientific
PMA number
P970034
Supplement
S006
Product code
HQL
Generic name
intraocular lens
Decision date
2000-08-31
Decision code
APPR
Date received
2000-04-19
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL TO EXTEND THE POWER RANGE FOR YOUR LENSES TO INCLUDE POWERS BETWEEN +3.5 AND -12.0 DIOPTERS (EXCLUDING ZERO DIOPTER) IN 0.5 DIOPTER INCREMENTS.