PMA P110005S012

Device: GELSYN-3
Applicant: Ibsa Institut Biochimique SA
PMA number: P110005
Supplement: S012
Product code: MOZ
Decision date: 2022-10-07
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for revisions to the Adverse Reactions section of the Product Information and Patient Information labeling based on post-market adverse event and safety data collected up to March 2022.

Current openFDA PMA Record#

Device: GELSYN-3
Applicant: Ibsa Institut Biochimique SA
PMA number: P110005
Supplement: S012
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2022-10-07
Decision code: APPR
Date received: 2022-09-08
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for revisions to the Adverse Reactions section of the Product Information and Patient Information labeling based on post-market adverse event and safety data collected up to March 2022.