PMA P950008S007

Device: SILIKON 1000
Applicant: Alcon
PMA number: P950008
Supplement: S007
Product code: LWL
Decision date: 2009-10-30
Classification: Fluid, Intraocular
Generic name: Fluid, intraocular
Approval order statement: APPROVAL FOR MODIFICATIONS OF SPECIFICATION RANGES FOR VISCOSITY AND MOLECULAR WEIGHT. THE CURRENT SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 900 ¿ 1,250 CS AND 32,850 ¿ 47,000 DALTONS, RESPECTIVELY. THE PROPOSED REGULATORY ACCEPTANCE SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 980 ¿ 1,350 CS AND 31,000 ¿ 44,500 DALTONS, RESPECTIVELY.

Current openFDA PMA Record#

Device: SILIKON 1000
Applicant: Alcon
PMA number: P950008
Supplement: S007
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2009-10-30
Decision code: APPR
Date received: 2009-05-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS OF SPECIFICATION RANGES FOR VISCOSITY AND MOLECULAR WEIGHT. THE CURRENT SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 900 ¿ 1,250 CS AND 32,850 ¿ 47,000 DALTONS, RESPECTIVELY. THE PROPOSED REGULATORY ACCEPTANCE SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 980 ¿ 1,350 CS AND 31,000 ¿ 44,500 DALTONS, RESPECTIVELY.