PMA P840064S041

Device: VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S041
Product code: LZP
Decision date: 2009-10-15
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: ALTERNATE PROCESS TO AUTOMATE THE REVIEW AND DOCUMENTATION OF LABORATORY AND PROCESS TEST RESULTS AS PART OF THE ELECTRONIC BATCH RECORD (EBR) SYSTEM.

Current openFDA PMA Record#

Device: VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S041
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2009-10-15
Decision code: OK30
Date received: 2009-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE PROCESS TO AUTOMATE THE REVIEW AND DOCUMENTATION OF LABORATORY AND PROCESS TEST RESULTS AS PART OF THE ELECTRONIC BATCH RECORD (EBR) SYSTEM.