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PMA P110005S003

Device
GELSYN-3
Applicant
Ibsa Institut Biochimique SA
PMA number
P110005
Supplement
S003
Product code
MOZ
Decision date
2018-05-07
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Approval for a labeling change to the Product Information leaflet for GELSYN-3 for incorporation of additional details in the instructions for removal of the syringe cap, securing of the needle to the syringe, and removal of the needle shield in preparation for injection of the product.

Current openFDA PMA Record#

Device
GELSYN-3
Applicant
Ibsa Institut Biochimique SA
PMA number
P110005
Supplement
S003
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2018-05-07
Decision code
APPR
Date received
2018-04-09
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a labeling change to the Product Information leaflet for GELSYN-3 for incorporation of additional details in the instructions for removal of the syringe cap, securing of the needle to the syringe, and removal of the needle shield in preparation for injection of the product.