PMA P840064S025

Device: DUOVISC VISCOELASTIC SYSTEM
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S025
Product code: LZP
Decision date: 2004-03-05
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL TO MODIFY THE PH RELEASE AND STABILITY SPECIFICATION RANGES FOR PROVISC OPHTHALMIC VISCOSURGICAL DEVICE CONTAINED WITHIN THE DUOVISC VISCOELASTIC SYSTEM FROM PH 7.0-7.3 TO PH 7.0-7.4 FOR RELEASE AND PH 7.0-7.5 TO PH 6.8-7.5 FOR STABILITY.

Current openFDA PMA Record#

Device: DUOVISC VISCOELASTIC SYSTEM
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S025
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2004-03-05
Decision code: APPR
Date received: 2004-02-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MODIFY THE PH RELEASE AND STABILITY SPECIFICATION RANGES FOR PROVISC OPHTHALMIC VISCOSURGICAL DEVICE CONTAINED WITHIN THE DUOVISC VISCOELASTIC SYSTEM FROM PH 7.0-7.3 TO PH 7.0-7.4 FOR RELEASE AND PH 7.0-7.5 TO PH 6.8-7.5 FOR STABILITY.