PMA P030016S039

Device: Visian Implantable Collamer Lens
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S039
Product code: MTA
Decision date: 2019-07-26
Classification: Lens, Intraocular, Phakic
Generic name: Lens, intraocular, phakic
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: Visian Implantable Collamer Lens
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S039
Product code: MTA
Generic name: Lens, intraocular, phakic
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.