PMA P990023S013

Device: CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Applicant: Alcon Laboratories
PMA number: P990023
Supplement: S013
Product code: LZP
Decision date: 2016-02-18
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Approval for an alternate packaging configuration (syringe, rubber tip cap, pouch), change in the release specification for pH, and change in the release and stability specification for osmolality.

Current openFDA PMA Record#

Device: CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Applicant: Alcon Laboratories
PMA number: P990023
Supplement: S013
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2016-02-18
Decision code: APPR
Date received: 2015-04-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for an alternate packaging configuration (syringe, rubber tip cap, pouch), change in the release specification for pH, and change in the release and stability specification for osmolality.