PMA P000046S001

Device: SHELLGEL(TM) SODIUM HYALURONATE
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S001
Product code: LZP
Decision date: 2001-06-11
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH CYTOSOL OPHTHALMICS, INC. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SHELLGEL(TM) SODIUM HYALURONATE.

Current openFDA PMA Record#

Device: SHELLGEL(TM) SODIUM HYALURONATE
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S001
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2001-06-11
Decision code: APPR
Date received: 2001-05-10
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH CYTOSOL OPHTHALMICS, INC. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SHELLGEL(TM) SODIUM HYALURONATE.