PMA P990013S035

Device
Collamer, UV-Absorbing Posterior Chamber Intraocular Lens
Applicant
Starr Surgical Co.
PMA number
P990013
Supplement
S035
Product code
HQL
Decision date
2017-06-16
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Adding an alternative water purification system to the STARR Surgical Monrovia, CA manufacturing site.

Current openFDA PMA Record#

Device
Collamer, UV-Absorbing Posterior Chamber Intraocular Lens
Applicant
Starr Surgical Co.
PMA number
P990013
Supplement
S035
Product code
HQL
Generic name
intraocular lens
Decision date
2017-06-16
Decision code
OK30
Date received
2017-05-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding an alternative water purification system to the STARR Surgical Monrovia, CA manufacturing site.