PMA P980040S147

Device
JJSV’s intraocular lenses (IOLs)
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P980040
Supplement
S147
Product code
HQL
Decision date
2022-05-18
Generic name
intraocular lens
Approval order statement
Perform the flat time test prior to sterilization as opposed to post sterilization.

Current openFDA PMA Record#

Device
JJSV’s intraocular lenses (IOLs)
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P980040
Supplement
S147
Product code
HQL
Generic name
intraocular lens
Decision date
2022-05-18
Decision code
OK30
Date received
2022-04-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Perform the flat time test prior to sterilization as opposed to post sterilization.