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PMA P110005S002

Device
GELSYN-3
Applicant
Ibsa Institut Biochimique SA
PMA number
P110005
Supplement
S002
Product code
MOZ
Decision date
2017-03-10
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Approval for revisions to the labeling of GELSYN-3 as follows: 1) Deletion of the statement, The safety and effectiveness of repeat treatment cycles of Gel-Syn have not been established from the Patient Information leaflet and addition of the statement, The effectiveness of repeat treatment cycles of GELSYN-3 has not been established. to the Product Information and Patient Information leaflets; and2) Addition of the statements, Adverse experience data from clinical use does not show an increased safety risk from retreatment with GELSYN-3. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle to the Product Information and Patient Information leaflets.

Current openFDA PMA Record#

Device
GELSYN-3
Applicant
Ibsa Institut Biochimique SA
PMA number
P110005
Supplement
S002
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2017-03-10
Decision code
APPR
Date received
2017-01-19
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to the labeling of GELSYN-3 as follows: 1) Deletion of the statement, The safety and effectiveness of repeat treatment cycles of Gel-Syn have not been established from the Patient Information leaflet and addition of the statement, The effectiveness of repeat treatment cycles of GELSYN-3 has not been established. to the Product Information and Patient Information leaflets; and2) Addition of the statements, Adverse experience data from clinical use does not show an increased safety risk from retreatment with GELSYN-3. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle to the Product Information and Patient Information leaflets.