PMA P840064S020

Device: VISCOAT(R)
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S020
Product code: LZP
Decision date: 1998-03-03
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Approval for a change in method of sterilization from 12/88 EtO/Freon mixture to 100% Ethylene Oxide for a 0.75 mL fill volume of VISCOAT at Alcon's Puerto Rico manufacturing facility.

Current openFDA PMA Record#

Device: VISCOAT(R)
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S020
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 1998-03-03
Decision code: APPR
Date received: 1996-12-04
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in method of sterilization from 12/88 EtO/Freon mixture to 100% Ethylene Oxide for a 0.75 mL fill volume of VISCOAT at Alcon's Puerto Rico manufacturing facility.