PMA P990013S040

Device
Collamer Intraocular Lens
Applicant
Starr Surgical Co.
PMA number
P990013
Supplement
S040
Product code
HQL
Decision date
2020-03-31
Generic name
intraocular lens
Approval order statement
Add an alternate in-process control method for collagen solution.

Current openFDA PMA Record#

Device
Collamer Intraocular Lens
Applicant
Starr Surgical Co.
PMA number
P990013
Supplement
S040
Product code
HQL
Generic name
intraocular lens
Decision date
2020-03-31
Decision code
OK30
Date received
2020-03-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add an alternate in-process control method for collagen solution.