GELSYN-3

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P110005 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceGELSYN-3
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantIBSA INSTITUT BIOCHIMIQUE SA
Date Received2017-01-19
Decision Date2017-03-10
PMAP110005
SupplementS002
Product CodeMOZ
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address IBSA INSTITUT BIOCHIMIQUE SA via Al Ponte 13, Ch-6903 lugano Ticino 6903

Supplemental Filings

Supplement NumberDateSupplement Type
P110005Original Filing
S009 2021-03-31 135 Review Track For 30-day Notice
S008 2021-03-03 30-day Notice
S007 2020-12-03 30-day Notice
S006 2020-09-04 30-day Notice
S005 2020-09-04 30-day Notice
S004 2020-06-29 Special (immediate Track)
S003 2018-04-09 Special (immediate Track)
S002 2017-01-19 Normal 180 Day Track
S001 2016-03-25 Real-time Process

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