PMA P840064S053

Device: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S053
Product code: LZP
Decision date: 2013-04-04
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: USE ONE GENERIC ¿WORST CASE¿ TEST BIOLOGICAL INDICATOR (BI) BLISTER AS AN ALTERNATIVE TO THE PRODUCT-SPECIFIC BI BLISTER FOR USE DURING ETO STERILIZATION.

Current openFDA PMA Record#

Device: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S053
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2013-04-04
Decision code: OK30
Date received: 2013-03-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE ONE GENERIC ¿WORST CASE¿ TEST BIOLOGICAL INDICATOR (BI) BLISTER AS AN ALTERNATIVE TO THE PRODUCT-SPECIFIC BI BLISTER FOR USE DURING ETO STERILIZATION.