PMA P990013S010

Device: STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S010
Product code: HQL
Decision date: 2007-03-23
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: REPLACEMENT OF HEXANE WITH WATER FOR CLEANING OF THE ARBORS AND THE ADDITION OF A VISUAL INSPECTION OF THE WAX QUANTITY TO THE ARBOR IN THE MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S010
Product code: HQL
Generic name: intraocular lens
Decision date: 2007-03-23
Decision code: OK30
Date received: 2007-02-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF HEXANE WITH WATER FOR CLEANING OF THE ARBORS AND THE ADDITION OF A VISUAL INSPECTION OF THE WAX QUANTITY TO THE ARBOR IN THE MANUFACTURING PROCESS.