PMA P110005

Device: Gelsyn-3
Applicant: Ibsa Institut Biochimique SA
PMA number: P110005
Supplement: S012
Product code: MOZ
Decision date: 2024-01-11
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for revisions to symbols utilized in the product labeling including the Product Information document, the needle label, and the product carton box label.

Current openFDA PMA Record#

Device: Gelsyn-3
Applicant: Ibsa Institut Biochimique SA
PMA number: P110005
Supplement: S014
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2024-01-11
Decision code: APPR
Date received: 2023-12-12
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for revisions to symbols utilized in the product labeling including the Product Information document, the needle label, and the product carton box label.