PMA P090031S006

Device: MONOVISC
Applicant: Anika Therapeutics, Inc.
PMA number: P090031
Supplement: S006
Product code: MOZ
Decision date: 2016-02-25
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for adding the following language to the Instructions for Use (IFU): “Intra-articular injection of sodium hyaluronate preparations has occasionally been associated with allergic/anaphylactic reactions and transient hypotension, which have generally resolved spontaneously or after conservative treatment.”

Current openFDA PMA Record#

Device: MONOVISC
Applicant: Anika Therapeutics, Inc.
PMA number: P090031
Supplement: S006
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2016-02-25
Decision code: APPR
Date received: 2016-02-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for adding the following language to the Instructions for Use (IFU): “Intra-articular injection of sodium hyaluronate preparations has occasionally been associated with allergic/anaphylactic reactions and transient hypotension, which have generally resolved spontaneously or after conservative treatment.”