PMA P030016S010

Device: STAAR SURGICAL COLLAMER UV ¿ ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S010
Product code: MTA
Decision date: 2008-09-04
Classification: Lens, Intraocular, Phakic
Generic name: Lens, intraocular, phakic
Approval order statement: CHANGE TO THE MODEL OF SILICONE/TEFLON SEPTA CURRENTLY USED TO MANUFACTURE COLLAMER¿ LENSES AT THE NIDAU, SWITZERLAND FACILITY.

Current openFDA PMA Record#

Device: STAAR SURGICAL COLLAMER UV ¿ ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S010
Product code: MTA
Generic name: Lens, intraocular, phakic
Decision date: 2008-09-04
Decision code: OK30
Date received: 2008-08-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE MODEL OF SILICONE/TEFLON SEPTA CURRENTLY USED TO MANUFACTURE COLLAMER¿ LENSES AT THE NIDAU, SWITZERLAND FACILITY.