PMA P990013S039

Device: Collamer Intraocular Lens - Alternat Environmental Monitoring Provider
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S039
Product code: HQL
Decision date: 2019-07-26
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Addition of the microbiology laboratory at the STAAR Surgical, Monrovia facility, as an alternate provider of environmental monitoring services for cleanrooms used to manufacture and process finished devices.

Current openFDA PMA Record#

Device: Collamer Intraocular Lens - Alternat Environmental Monitoring Provider
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S039
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-07-26
Decision code: OK30
Date received: 2019-06-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of the microbiology laboratory at the STAAR Surgical, Monrovia facility, as an alternate provider of environmental monitoring services for cleanrooms used to manufacture and process finished devices.