PMA P010027S004

Device
ANTERIOR CHAMBER INTRAOCULAR LENS
Applicant
Aaren Scientific
PMA number
P010027
Supplement
S004
Product code
HQL
Decision date
2012-03-02
Generic name
intraocular lens
Approval order statement
ALTERNATE VENDOR TO PERFORM LIMULUS AMEBOCYTE LYSATE (LAL) TESTING.

Current openFDA PMA Record#

Device
ANTERIOR CHAMBER INTRAOCULAR LENS
Applicant
Aaren Scientific
PMA number
P010027
Supplement
S004
Product code
HQL
Generic name
intraocular lens
Decision date
2012-03-02
Decision code
OK30
Date received
2012-02-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE VENDOR TO PERFORM LIMULUS AMEBOCYTE LYSATE (LAL) TESTING.